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RecruitingNCT05399745BILACOUpdated Jun 1, 2022

BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease

An observational study in Biliary Atresia and Cognitive Impairment, sponsored by Copenhagen University Hospital, Rigshospitalet. Recruiting at 1 site in Denmark. Open to participants aged 0 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
0 Years to 18 Years
Sex
All
01

Study summary

Biliary atresia is the most severe form of cholestatic liver disease. The children have high morbidity and mortality and get devastating pruritus and fatigue, failure to thrive, progressive hepatic failure and impaired neurodevelopment. The etiology is mostly unknown. More than half need a new liver from a living or deceased donor during childhood. However, correct timing of the transplantation is extremely difficult because of lack of consensus based on clinical assessment tools. All though the incidence is low, the cost of this disease is tremendous from both a clinical and human perspective. So far, protocolized neurodevelopment tests, genetic profiling, precise malnutrition evaluation based on clinical appearance, biochemical markers and brain MRI-scans, body composition, immunological function, level of physical activity and optimal time of transplantation in cholestatic children are unknown.

The aim is to determine risk factors for neurocognitive impairment in children suffering from severe cholestasis in order to determine optimal time for liver transplantation from a brain perspective.

In a prospective study, the investigators will investigate risk factors related to brain-, heart-, gut- and immunological function in the Danish cohort. This cohort consists of 75 children aged 0-18 years. In addition, 30 aged and gender matched healthy and 20 tetra fallot children will serve as control groups. The children will undergo extensive and advanced liver function evaluation, genetic profiling, nutrition and immunological status, neuro-imaging and neurocognitive evaluation at time of diagnose, 2 years of age, pre-school, pre-teenage, and teenage. In case of a liver transplantation, additional neuro-cognitive tests will be performed

02

Conditions studied

  • Biliary Atresia
  • Cognitive Impairment
03

In context

Biliary Atresia

77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 33 observational studies indexed under Biliary Atresia.

Browse Biliary Atresia studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children with biliary atresia (BA), children with Tetralogy of Fallot (ToF) and healthy control children between the age of 0-17 years. The BA and ToF children were recruited from their respective outpatient clinics at Rigshospitalet, Denmark, which is the only centre treating these patients. Healthy controls were siblings to BA children, recruited from staffs children and friends or recruited from a general practitioners office in Nivaa, Denmark. The recruitment took place from March 2020 and is ongoing

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Biliary atresia
  • Tetralogy of Fallot
  • Healthy controls

Exclusion criteria

Exclusion Criteria:

- Not able to participate in exams

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children with biliary atresia

    Other: Neurocognitive monitoring

  • Children with Tetralogy of Fallot

    Other: Neurocognitive monitoring

  • Healthy control children

    Other: Neurocognitive monitoring

Interventions

  • OtherNeurocognitive monitoring

    Neurocognitive tests and MRI of the brain

06

What researchers measure

Primary outcomes

  1. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: Inclusion

  2. Neurocognitive status: Early movement repertoire (General movement)

    Neurocognitive test panel depending on age at inclusion % of patients with of abnormal movement assessed using early movement repertoire (GM) if inclusion at diagnosis. Early movement repertoire is a measurement tool where abnormal movement is identified.

    Time frame: Inclusion

  3. Neurocognitive status: Alberta Infant Motor Scale

    Neurocognitive test panel depending on age at inclusion: Alberta Infant Motor Scale if inclusion at diagnosis Percentile, highest is the best

    Time frame: Inclusion

  4. Neurocognitive status: Bayley Scales of Development III

    Neurocognitive test panel depending on age at inclusion: Bayley Scales of Development III if inclusion up to 2.5 years: From 0-200, highest is best

    Time frame: Inclusion

  5. Neurocognitive status: WIPPSI

    Neurocognitive test panel depending on age at inclusion: WIPPSI if inclusion between 2.5-6 years: Wechsler Preschool and Primary Scale of Intelligence, from 41 to 160, highest is best

    Time frame: Inclusion

  6. Neurocognitive status: ABC Movement

    Neurocognitive test panel depending on age at inclusion: ABC Movement if inclusion between 2.5-16 years Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Time frame: Inclusion

  7. Neurocognitive status: WISC-IV

    Neurocognitive test panel depending on age at inclusion: WISC-IV if inclusion between 6-16 years Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Time frame: Inclusion

  8. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Neurocognitive test panel depending on age at inclusion: Auditory Verbal Learning Test/ToMaL if inclusion between 6-18 years Mean 10 SD 3, highest is best

    Time frame: Inclusion

  9. Neurocognitive status: TEA-Ch

    Neurocognitive test panel depending on age at inclusion: TEA-Ch if inclusion between 6-18 years Test of Everyday Attention for Children, normalized to z-score, highest is best

    Time frame: Inclusion

  10. Neurocognitive status: BADS-C

    Neurocognitive test panel depending on age at inclusion: BADS-C if inclusion between 6-18 years Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Time frame: Inclusion

  11. Neurocognitive status: Test of Visual Perceptual Skills

    Neurocognitive test panel depending on age at inclusion: Test of Visual Perceptual Skills if inclusion between 6-18 years Percentile, highest is best

    Time frame: Inclusion

  12. Neurocognitive status: CANTAB

    Neurocognitive test panel depending on age at inclusion: CANTAB if inclusion between 6-18 years Cambridge Neuropsychological Test Automated Battery

    Time frame: Inclusion

  13. Neurocognitive status: The Beery Visuo-Motor Integration test

    Neurocognitive test panel depending on age at inclusion: The Beery Visuo-Motor Integration test if inclusion between 6-18 years Mean of 100 and standard deviation of 15, highest is best

    Time frame: Inclusion

  14. Neurocognitive status: WAIS IV

    Neurocognitive test panel depending on age at inclusion: WAIS IV if inclusion from 16 to 18 years Wechsler Adult Intelligence Scale, 40-160, highest is best

    Time frame: Inclusion

  15. Neurocognitive status: Kiddie-sads

    Neurocognitive test panel depending on age at inclusion: Kiddie-sads if included between 2-18 years Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: Inclusion

  16. Neurocognitive status: BRIEF 1

    Neurocognitive test panel depending on age at inclusion: BRIEF 1 if inclusion up to 6 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: Inclusion

  17. Neurocognitive status: BRIEF 2

    Neurocognitive test panel depending on age at inclusion: BRIEF 2 if inclusion between 6-18 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: Inclusion

  18. Neurocognitive status: CBCL

    Neurocognitive test panel depending on age at inclusion: CBCL if included between 2-18 years Child Behavior Checklist, percentile, lowest is best

    Time frame: Inclusion

  19. Neurocognitive status: ADHD screening

    Neurocognitive test panel depending on age at inclusion: ADHD screening if included between 2-18 years Lowest is best, 0-78

    Time frame: Inclusion

  20. Neurocognitive status: SRS-2

    Neurocognitive test panel depending on age at inclusion: SRS-2 screening if included between 6-18 years Social Responsiveness Scale, 32-114. lowest is best

    Time frame: Inclusion

  21. Neurocognitive status: Vineland

    Neurocognitive test panel depending on age at inclusion: Vineland screening if included between 6-18 years Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Time frame: Inclusion

  22. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: 1 year

  23. Neurocognitive status: Alberta Infant Motor Scale

    Alberta Infant Motor Scale Percentile, highest is the best

    Time frame: 1 year

  24. Neurocognitive status: Bayley Scales of Development III

    Bayley Scales of Development III From 0-200, highest is best

    Time frame: 1 year

  25. Neurocognitive status: BRIEF 1

    BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: 1 year

  26. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Time frame: 1 year

  27. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: 1 year

  28. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: 2 years

  29. Neurocognitive status: Bayley Scales of Development III

    Bayley Scales of Development III From 0-200, highest is best

    Time frame: 2 years

  30. Neurocognitive status: BRIEF 1

    BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: 2 years

  31. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Time frame: 2 years

  32. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: 2 years

  33. Neurocognitive status: ADHD

    ADHD Lowest is best, 0-78

    Time frame: 2 years

  34. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Time frame: 2 years

  35. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: 6 years

  36. Neurocognitive: Movement ABC

    Neurocognitive test panel depending on age Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Time frame: 6 years

  37. Neurocognitive status: WISC-IV

    WISC-IV Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Time frame: 6 years

  38. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Time frame: 6 years

  39. Neurocognitive status: TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Time frame: 6 years

  40. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Time frame: 6 years

  41. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Time frame: 6 years

  42. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Time frame: 6 years

  43. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Time frame: 6 years

  44. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: 6 years

  45. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Time frame: 6 years

  46. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Time frame: 6 years

  47. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: 6 years

  48. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Time frame: 6 years

  49. Neurocognitive status: Vineland

    Vineland Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Time frame: 6 years

  50. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: 11 years

  51. Neurocognitive status: Movement ABC

    Neurocognitive test panel depending on age at inclusion: ABC Movement if inclusion between 2.5-16 years Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Time frame: 11 years

  52. Neurocognitive status: WISC-IV

    WISC-IV Wechsler Intelligence Scale for Children, 40 to 160, highest is best

    Time frame: 11 years

  53. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Time frame: 11 years

  54. Neurocognitive status:TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Time frame: 11 years

  55. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Time frame: 11 years

  56. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Time frame: 11 years

  57. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Time frame: 11 years

  58. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Time frame: 11 years

  59. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: 11 years

  60. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Time frame: 11 years

  61. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Time frame: 11 years

  62. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: 11 years

  63. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Time frame: 11 years

  64. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Time frame: 11 years

  65. MRI of the brain

    % of patients with anatomic anomalies on MRI of the brain

    Time frame: 16 years

  66. Neurocognitive status: Movement ABC

    Neurocognitive test panel depending on age at inclusion: ABC Movement if inclusion between 2.5-16 years Movement Assessment Battery for Children, mean 10 SD 3, highest is best

    Time frame: 16 years

  67. Neurocognitive status: WISC-IV

    WISC-IV Wechsler Adult Intelligence Scale, 40-160, highest is best

    Time frame: 16 years

  68. Neurocognitive status: Auditory Verbal Learning Test/ToMaL

    Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best

    Time frame: 16 years

  69. Neurocognitive status: TEA-Ch

    TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best

    Time frame: 16 years

  70. Neurocognitive status: BADS-C

    BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best

    Time frame: 16 years

  71. Neurocognitive status: Test of Visual Perceptual Skills

    Test of Visual Perceptual Skills Percentile, highest is best

    Time frame: 16 years

  72. Neurocognitive status: The Beery Visuo-Motor Integration test

    The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best

    Time frame: 16 years

  73. Neurocognitive status: CANTAB

    CANTAB Cambridge Neuropsychological Test Automated Battery

    Time frame: 16 years

  74. Neurocognitive status: BRIEF 2

    BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best

    Time frame: 16 years

  75. Neurocognitive status: ADHD screening

    ADHD screening Lowest is best, 0-78

    Time frame: 16 years

  76. Neurocognitive status: SRS-2

    SRS-2 Social Responsiveness Scale, 32-114. lowest is best

    Time frame: 16 years

  77. Neurocognitive status: Kiddie-Sads

    Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best

    Time frame: 16 years

  78. Neurocognitive status: CBCL

    CBCL Child Behavior Checklist, percentile, lowest is best

    Time frame: 16 years

  79. Neurocognitive status: Vineland

    Vineland Adaptive Behavior Scales, 20 to 160, highest is best

    Time frame: 16 years

Secondary outcomes

  1. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: Inclusion

  2. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: Inclusion

  3. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: Inclusion

  4. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: Inclusion

  5. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: Inclusion

  6. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurement on feces

    Time frame: Inclusion

  7. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurement on urine

    Time frame: Inclusion

  8. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurement on saliva

    Time frame: Inclusion

  9. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: Inclusion

  10. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: Inclusion

  11. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: Inclusion

  12. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: Inclusion

  13. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: Inclusion

  14. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: Inclusion

  15. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: 1 year

  16. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: 1 year

  17. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: 1 year

  18. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: 1 year

  19. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: 1 year

  20. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Time frame: 1 year

  21. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Time frame: 1 year

  22. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Time frame: 1 year

  23. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: 1 year

  24. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: 1 year

  25. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: 1 year

  26. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: 1 year

  27. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: 1 year

  28. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: 1 year

  29. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: 2 years

  30. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: 2 years

  31. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: 2 years

  32. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: 2 years

  33. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: 2 years

  34. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: 2 years

  35. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: 2 years

  36. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: 2 years

  37. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: 2 years

  38. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: 2 years

  39. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: 2 years

  40. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Time frame: 2 years

  41. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Time frame: 2 years

  42. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Time frame: 2 years

  43. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: 6 years

  44. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: 6 years

  45. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Time frame: 6 years

  46. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: 6 years

  47. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: 6 years

  48. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: 6 years

  49. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Time frame: 6 years

  50. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: 6 years

  51. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: 6 years

  52. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: 6 years

  53. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Time frame: 6 years

  54. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: 6 years

  55. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: 6 years

  56. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: 6 years

  57. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: 11 years

  58. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: 11 years

  59. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Time frame: 11 years

  60. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: 11 years

  61. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: 11 years

  62. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: 11 years

  63. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Time frame: 11 years

  64. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: 11 years

  65. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: 11 years

  66. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: 11 years

  67. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Time frame: 11 years

  68. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: 11 years

  69. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: 11 years

  70. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: 11 years

  71. Genetics: Whole genome sequencing of blood

    Whole genome sequencing of blood

    Time frame: 16 years

  72. Genetics: Whole genome sequencing of liver biopsy

    Whole genome sequencing of liver biopsy

    Time frame: 16 years

  73. Microbiome: Feces metatranscriptomics

    Microbiome measurements on feces

    Time frame: 16 years

  74. Microbiome: Feces Next Generation Sequencing of microbial DNA

    Microbiome measurements on feces

    Time frame: 16 years

  75. Microbiome: Feces metabolomics

    Microbiome measurements on feces

    Time frame: 16 years

  76. Microbiome: Feces proteomics

    Microbiome measurements on feces

    Time frame: 16 years

  77. Microbiome: Urine metatranscriptomics

    Microbiome measurements on urine

    Time frame: 16 years

  78. Microbiome: Urine Next Generation Sequencing of microbial DNA

    Microbiome measurements on urine

    Time frame: 16 years

  79. Microbiome: Urine metabolomics

    Microbiome measurements on urine

    Time frame: 16 years

  80. Microbiome: Urine proteomics

    Microbiome measurements on urine

    Time frame: 16 years

  81. Microbiome: Saliva metatranscriptomics

    Microbiome measurements on saliva

    Time frame: 16 years

  82. Microbiome: Saliva Next Generation Sequencing of microbial DNA

    Microbiome measurements on saliva

    Time frame: 16 years

  83. Microbiome: Saliva metabolomics

    Microbiome measurements on saliva

    Time frame: 16 years

  84. Microbiome: Saliva proteomics

    Microbiome measurements on saliva

    Time frame: 16 years

  85. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: Inclusion

  86. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: Inclusion

  87. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: Inclusion

  88. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: 1 year

  89. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: 1 year

  90. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: 1 year

  91. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: 2 years

  92. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: 2 years

  93. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: 2 years

  94. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: 6 years

  95. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: 6 years

  96. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: 6 years

  97. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: 11 years

  98. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: 11 years

  99. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: 11 years

  100. Status of the cardiac system: Ultrasound of the heart

    % of patients with anatomic anomalies on ultrasound of the heart

    Time frame: 16 years

  101. Status of the cardiac system: MRI of the lymph system

    % of patients with central lymph system anomaly

    Time frame: 16 years

  102. Status of the cardiac system: Near Infrared Fluorescence of the lymph system

    Near Infrared Fluorescence of the lymph system

    Time frame: 16 years

  103. Level of Physical activity

    Accelerometer measurements

    Time frame: Inclusion

  104. Level of Physical activity

    Accelerometer measurements

    Time frame: 1 year

  105. Level of Physical activity

    Accelerometer measurements

    Time frame: 2 years

  106. Level of Physical activity

    Accelerometer measurements

    Time frame: 6 years

  107. Level of Physical activity

    Accelerometer measurements

    Time frame: 11 years

  108. Level of Physical activity

    Accelerometer measurements

    Time frame: 16 years

  109. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: Inclusion

  110. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: Inclusion

  111. FGF-19; Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: Inclusion

  112. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: Inclusion

  113. INR: international normalized ratio

    Standard liver evaluation

    Time frame: Inclusion

  114. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: Inclusion

  115. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: Inclusion

  116. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: Inclusion

  117. Bilirubin

    Standard liver evaluation

    Time frame: Inclusion

  118. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: Inclusion

  119. Alkaline phosphatase

    Standard liver evaluation

    Time frame: Inclusion

  120. Ammonia

    Standard liver evaluation

    Time frame: Inclusion

  121. Thrombocytes

    Standard liver evaluation

    Time frame: Inclusion

  122. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: 1 year

  123. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: 1 year

  124. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: 1 year

  125. INR: international normalized ratio

    Standard liver evaluation

    Time frame: 1 year

  126. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: 1 year

  127. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: 1 year

  128. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: 1 year

  129. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: 1 year

  130. Bilirubin

    Standard liver evaluation

    Time frame: 1 year

  131. Alkaline phosphatase

    Standard liver evaluation

    Time frame: 1 year

  132. Ammonia

    Standard liver evaluation

    Time frame: 1 year

  133. Thrombocytes

    Standard liver evaluation

    Time frame: 1 year

  134. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: 1 year

  135. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: 2 years

  136. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: 2 years

  137. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: 2 years

  138. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: 2 years

  139. INR: international normalized ratio

    Standard liver evaluation

    Time frame: 2 years

  140. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: 2 years

  141. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: 2 years

  142. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: 2 years

  143. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: 2 years

  144. Alkaline phosphatase

    Standard liver evaluation

    Time frame: 2 years

  145. Bilirubin

    Standard liver evaluation

    Time frame: 2 years

  146. Ammonia

    Standard liver evaluation

    Time frame: 2 years

  147. Thrombocytes

    Standard liver evaluation

    Time frame: 2 years

  148. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: 6 years

  149. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: 6 years

  150. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: 6 years

  151. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: 6 years

  152. INR: international normalized ratio

    Standard liver evaluation

    Time frame: 6 years

  153. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: 6 years

  154. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: 6 years

  155. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: 6 years

  156. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: 6 years

  157. Bilirubin

    Standard liver evaluation

    Time frame: 6 years

  158. Alkaline phosphatase

    Standard liver evaluation

    Time frame: 6 years

  159. Ammonia

    Standard liver evaluation

    Time frame: 6 years

  160. Thrombocytes

    Standard liver evaluation

    Time frame: 6 years

  161. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: 11 years

  162. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: 11 years

  163. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: 11 years

  164. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: 11 years

  165. INR: international normalized ratio

    Standard liver evaluation

    Time frame: 11 years

  166. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: 11 years

  167. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: 11 years

  168. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: 11 years

  169. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: 11 years

  170. Bilirubin

    Standard liver evaluation

    Time frame: 11 years

  171. Alkaline phosphatase

    Standard liver evaluation

    Time frame: 11 years

  172. Ammonia

    Standard liver evaluation

    Time frame: 11 years

  173. Thrombocytes

    Standard liver evaluation

    Time frame: 11 years

  174. Ultrasound of liver and bile ducts with elastography

    % of patients with liver fibrosis measured with ultrasound

    Time frame: 16 years

  175. Liver biopsy

    Level of liver fibrosis (grade 0-4)

    Time frame: 16 years

  176. FGF-19: Fibroblast growth factor 19

    Liver fibrosis status

    Time frame: 16 years

  177. ELF-score: Enhanced Liver Fibrosis

    Liver fibrosis status

    Time frame: 16 years

  178. INR: international normalized ratio

    Standard liver evaluation

    Time frame: 16 years

  179. prothrombin+proconvertin (PP)

    Standard liver evaluation

    Time frame: 16 years

  180. ALAT: alanine transaminase

    Standard liver evaluation

    Time frame: 16 years

  181. ASAT: Aspartate transaminase

    Standard liver evaluation

    Time frame: 16 years

  182. GGT: Gamma-glutamyl transferase

    Standard liver evaluation

    Time frame: 16 years

  183. Bilirubin

    Standard liver evaluation

    Time frame: 16 years

  184. Alkaline phosphatase

    Standard liver evaluation

    Time frame: 16 years

  185. Ammonia

    Standard liver evaluation

    Time frame: 16 years

  186. Thrombocytes

    Standard liver evaluation

    Time frame: 16 years

  187. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: Inclusion

  188. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: 1 year

  189. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: 2 years

  190. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: 6 years

  191. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: 11 years

  192. Clinical examination: Cirrhosis stigmata

    Incidence of spider angioma

    Time frame: 16 years

  193. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: Inclusion

  194. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: 1 year

  195. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: 2 years

  196. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: 6 years

  197. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: 11 years

  198. Clinical examination: Cirrhosis stigmata

    Incidence of ascitis

    Time frame: 16 years

  199. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: Inclusion

  200. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: 1 year

  201. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: 2 years

  202. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: 6 years

  203. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: 11 years

  204. Clinical examination: Cirrhosis stigmata

    Incidence of palmar erythema

    Time frame: 16 years

  205. Anthropometry: Length

    cm

    Time frame: Inclusion

  206. Anthropometry: Length

    cm

    Time frame: 1 year

  207. Anthropometry: Length

    cm

    Time frame: 2 years

  208. Anthropometry: Height

    cm

    Time frame: 6 years

  209. Anthropometry: Height

    cm

    Time frame: 11 years

  210. Anthropometry: Height

    cm

    Time frame: 16 years

  211. Anthropometry: Weight

    kg

    Time frame: Inclusion

  212. Anthropometry: Weight

    kg

    Time frame: 1 year

  213. Anthropometry: Weight

    kg

    Time frame: 2 years

  214. Anthropometry: Weight

    kg

    Time frame: 6 years

  215. Anthropometry: Weight

    kg

    Time frame: 11 years

  216. Anthropometry: Weight

    kg

    Time frame: 16 years

  217. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: Inclusion

  218. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: 1 year

  219. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: 2 years

  220. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: 6 years

  221. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: 11 years

  222. Anthropometry: Mid-upper arm circumference (MUAC)

    mm

    Time frame: 16 years

  223. Anthropometry: Head circumference

    cm

    Time frame: Inclusion

  224. Anthropometry: Head circumference

    cm

    Time frame: 1 year

  225. Anthropometry: Head circumference

    cm

    Time frame: 2 years

  226. Anthropometry: Head circumference

    cm

    Time frame: 6 years

  227. Anthropometry: Head circumference

    cm

    Time frame: 11 years

  228. Anthropometry: Head circumference

    cm

    Time frame: 16 years

  229. Essential fatty acids

    Time frame: Inclusion

  230. Essential fatty acids

    Time frame: 1 year

  231. Essential fatty acids

    Time frame: 2 years

  232. Essential fatty acids

    Time frame: 6 years

  233. Essential fatty acids

    Time frame: 11 years

  234. Essential fatty acids

    Time frame: 16 years

  235. IGF-1

    Insulin-like growth factor 1

    Time frame: Inclusion

  236. IGF-1

    Insulin-like growth factor 1

    Time frame: 1 year

  237. IGF-1

    Insulin-like growth factor 1

    Time frame: 2 years

  238. IGF-1

    Insulin-like growth factor 1

    Time frame: 6 years

  239. IGF-1

    Insulin-like growth factor 1

    Time frame: 11 years

  240. IGF-1

    Insulin-like growth factor 1

    Time frame: 16 years

  241. Meal stimulation measuring incretin

    Time frame: Inclusion

  242. Meal stimulation measuring incretin

    Time frame: 1 year

  243. Meal stimulation measuring incretin

    Time frame: 2 years

  244. Meal stimulation measuring incretin

    Time frame: 6 years

  245. Meal stimulation measuring incretin

    Time frame: 11 years

  246. Meal stimulation measuring incretin

    Time frame: 16 years

  247. Bile acid

    Time frame: Inclusion

  248. Bile acid

    Time frame: 1 year

  249. Bile acid

    Time frame: 2 years

  250. Bile acid

    Time frame: 6 years

  251. Bile acid

    Time frame: 11 years

  252. Bile acid

    Time frame: 16 years

  253. Autotaxin

    Time frame: Inclusion

  254. Autotaxin

    Time frame: 1 year

  255. Autotaxin

    Time frame: 2 years

  256. Autotaxin

    Time frame: 6 years

  257. Autotaxin

    Time frame: 11 years

  258. Autotaxin

    Time frame: 16 years

  259. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: Inclusion

  260. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: 1 year

  261. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: 2 years

  262. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: 6 years

  263. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: 11 years

  264. EDTA clearance

    Glomerular Filtration Rate Measured by 51 Cr-EDTA Clearance

    Time frame: 16 years

  265. Vaccination status

    Level of antibodies

    Time frame: Inclusion

  266. Vaccination status

    Level of antibodies

    Time frame: 1 year

  267. Vaccination status

    Level of antibodies

    Time frame: 2 years

  268. Vaccination status

    Level of antibodies

    Time frame: 6 years

  269. Vaccination status

    Level of antibodies

    Time frame: 11 years

  270. Vaccination status

    Level of antibodies

    Time frame: 16 years

  271. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: Inclusion

  272. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: 1 year

  273. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: 2 years

  274. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: 6 years

  275. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: 11 years

  276. Immunoresponse: RTE

    Recent thymic emigrants

    Time frame: 16 years

  277. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: Inclusion

  278. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: 1 year

  279. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: 2 years

  280. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: 6 years

  281. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: 11 years

  282. Immunoresponse: Flow panel

    T-cell differentiation

    Time frame: 16 years

  283. Immunoresponse: Immunoglobulin

    Time frame: Inclusion

  284. Immunoresponse: Immunoglobulin

    Time frame: 1 year

  285. Immunoresponse: Immunoglobulin

    Time frame: 2 years

  286. Immunoresponse: Immunoglobulin

    Time frame: 6 years

  287. Immunoresponse: Immunoglobulin

    Time frame: 11 years

  288. Immunoresponse: Immunoglobulin

    Time frame: 16 years

  289. Immunoresponse: Somatic hyper mutation

    Time frame: Inclusion

  290. Immunoresponse: Somatic hyper mutation

    Time frame: 1 year

  291. Immunoresponse: Somatic hyper mutation

    Time frame: 2 years

  292. Immunoresponse: Somatic hyper mutation

    Time frame: 6 years

  293. Immunoresponse: Somatic hyper mutation

    Time frame: 11 years

  294. Immunoresponse: Somatic hyper mutation

    Time frame: 16 years

  295. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: Inclusion

  296. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: 1 year

  297. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: 2 years

  298. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: 6 years

  299. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: 11 years

  300. Epstein-Barr Virus (EBV)

    level of EBV DNA present

    Time frame: 16 years

  301. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: Inclusion

  302. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: 1 year

  303. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: 2 years

  304. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: 6 years

  305. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: 11 years

  306. Cytomegalovirus (CMV)

    level of CMV DNA present

    Time frame: 16 years

  307. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: Inclusion

  308. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: 1 year

  309. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: 2 years

  310. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: 6 years

  311. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: 11 years

  312. Hepatobiliary scintigraphy

    Hepatic extraction fraction

    Time frame: 16 years

  313. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: Inclusion

  314. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: 1 year

  315. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: 2 years

  316. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: 6 years

  317. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: 11 years

  318. MRI of liver and bile ducts with elastography

    Liver stiffness

    Time frame: 16 years

  319. Fibroscan

    Liver stiffness (number)

    Time frame: Inclusion

  320. Fibroscan

    Liver stiffness (number)

    Time frame: 1 year

  321. Fibroscan

    Liver stiffness (number)

    Time frame: 2 years

  322. Fibroscan

    Liver stiffness (number)

    Time frame: 6 years

  323. Fibroscan

    Liver stiffness (number)

    Time frame: 11 years

  324. Fibroscan

    Liver stiffness (number)

    Time frame: 16 years

  325. Indocyanine green clearance

    Time frame: Inclusion

  326. Indocyanine green clearance

    Time frame: 1 year

  327. Indocyanine green clearance

    Time frame: 2 years

  328. Indocyanine green clearance

    Time frame: 6 years

  329. Indocyanine green clearance

    Time frame: 11 years

  330. Indocyanine green clearance

    Time frame: 16 years

  331. Fecal fat measurements

    Time frame: Inclusion

  332. Fecal fat measurements

    Time frame: 1 year

  333. Fecal fat measurements

    Time frame: 2 years

  334. Fecal fat measurements

    Time frame: 6 years

  335. Fecal fat measurements

    Time frame: 11 years

  336. Fecal fat measurements

    Time frame: 16 years

  337. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: Inclusion

  338. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: 1 year

  339. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: 2 years

  340. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: 6 years

  341. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: 11 years

  342. Thymus scan with ultrasound

    Thymic index (measurement of size)

    Time frame: 16 years

  343. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: Inclusion

  344. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: 1 year

  345. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: 2 years

  346. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: 6 years

  347. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: 11 years

  348. DEXA scan

    Dual energy x-ray absorptiometry

    Time frame: 16 years

  349. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: Inclusion

  350. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: 1 year

  351. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: 2 years

  352. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: 6 years

  353. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: 11 years

  354. PEDS-QL

    Pediatric Quality of Life Inventory Higher scores indicate better quality of life, from 0-100

    Time frame: 16 years

  355. Leptin

    Time frame: Inclusion

  356. Leptin

    Time frame: 1 year

  357. Leptin

    Time frame: 2 years

  358. Leptin

    Time frame: 6 years

  359. Leptin

    Time frame: 11 years

  360. Leptin

    Time frame: 16 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No allowed from Danish government

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Dec 2039, 237 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2022
First posted
Jun 1, 2022
StartActual
Mar 1, 2020
Primary completionEst.
Dec 31, 2039
CompletionEst.
Dec 31, 2040
Last update
Jun 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05399745
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Vibeke Brix Christensen (Principal investigator, MD, PhD, DMSc, senior consultant, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Jun 1, 2022
Start date
Mar 1, 2020
Primary completion
Dec 31, 2039 (estimated)
Completion
Dec 31, 2040 (estimated)
Last update
Jun 1, 2022

Study contacts

Vibeke Brix Christensen, MD, PhD, DMSc
Contact
vibeke.brix.christensen@regionh.dk
+4535458842
Vibeke Brix Christensen, MD, PhD, DMSc
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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