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CompletedNCT05323370LAM-CAKUpdated Mar 29, 2023

Lymphangioleiomyomatosis, a Study on Cathepsin K

An observational study in Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
Female
01

Study summary

This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.

02

Conditions studied

  • Lymphangioleiomyomatosis
  • Tuberous Sclerosis Complex

Keywords

  • urine
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In context

Lymphangioleiomyomatosis

48 studies on the registry are indexed under Lymphangioleiomyomatosis; 11 are open to participants now.

This study's enrollment of 19 is below the median of 200 across 17 observational studies indexed under Lymphangioleiomyomatosis.

Browse Lymphangioleiomyomatosis studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 306 studies on the registry; 78 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult female patients with lymphangioleiomyomatosis or with tuberous sclerosis complexwithout AML or healthy volunteers

Eligibility criteria

Inclusion criteria for patients with lymphangioleiomyomatosis

  • Age ≥ 18 years
  • Female carrier of lymphangioleiomyomatosis according to ERS criteria

Inclusion criteria for healthy female volunteers

  • Age ≥ 18 years
  • Women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease

Inclusion criteria for tuberous sclerosis complex patients without lymphangioleiomyomatosis

  • Age ≥ 18 years
  • Woman followed for tuberous sclerosis complex for whom a chest CT scan less than 3 years old does not objectify a pulmonary cyst. (= without lymphangioleiomyomatosis)

Non-inclusion criteria

  • Woman under judicial protection
  • Woman with a urinary tract infection within 15 days
  • Person who objected to the data processing
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patientes with lymphangioleiomyomatosis

    no intervention administered. Recruitment in pneumology department

    Other: 24h urine · Other: urine sample

  • Patientes with tuberous sclerosis complex without Lymphangioleiomyomatosis

    no intervention administered. Recruitment in neurology department

    Other: 24h urine · Other: urine sample

  • Healthy women volunteers

    no intervention administered. Recruitment in clinical investigation centre

    Other: 24h urine · Other: urine sample

Interventions

  • Other24h urine

    Urine samples will be collected at home over 24 hours

  • Otherurine sample

    A urine sample of 20cc will be collected

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What researchers measure

Primary outcomes

  1. urine cathepsin K proteins levels

    comparison of urine cathepsin K protein levels in the 3 groups

    Time frame: inclusion visit

  2. urine cathepsin K activity

    comparison of urine cathepsin K activity in the 3 groups

    Time frame: inclusion visit

Secondary outcomes

  1. urinary quantity of cystatin C

    comparison of urine cystacin C quantity in the 3 groups

    Time frame: inclusion visit

  2. urinary quantity C and N-telopeptides of type 1 collagen

    comparison in the 3 groups

    Time frame: inclusion visit

  3. serum level of chondroitin sulphates

    measurement in lymphangioleiomyomatosis patients

    Time frame: inclusion visit

  4. renal angiolipomas

    measurement of the size of renal angiomyolipomas in lymphangioleiomyomatosis patients

    Time frame: inclusion visit

  5. FEV1 measurement

    most recent FEV1 measurement as % of predicted value in lymphangioleiomyomatosis patients

    Time frame: inclusion visit

  6. VEGF-D measurement

    most recent measurement of VEGF-D blood levels in lymphangioleiomyomatosis patients

    Time frame: inclusion visit

  7. T-score measurement

    T-score measurement of the most recent bone densitometry in lymphangioleiomyomatosis patients

    Time frame: inclusion visit

07

Study locations

1 site
  • University hospital
    Tours, 37044, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05323370
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
May 31, 2022
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Mar 29, 2023

Study contacts

Sylvain MARCHAND-ADAM
principal investigator · University Hospital, Tours

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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