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Status unknownNCT03222947NewViTALSUpdated Jul 19, 2017

New Variants Involved in Taybi-Linder Syndrome

An observational study in Taybi Linder Syndrome and Genetic Syndrome, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2017-07-19.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
19
Sex
All
01

Study summary

Taybi-Linder syndrome (TALS, OMIM 210710) is a rare autosomal recessive disorder belonging to the group of microcephalic osteodysplastic primordial dwarfisms (MOPD). This syndrome is characterized by short stature, skeletal anomalies, severe microcephaly with brain malformations and facial dysmorphism, and is caused by mutations in RNU4ATAC. Although RNU4ATAC-associated TALS is a recognizable phenotype, an atypical presentation is sometimes observed, thus expanding the clinical spectrum (TALS-like phenotype).

This study aims to identify new variants involved in Taybi-Linder syndrome and associated phenotypes (i.e.TALS-like).

This non interventional study will be performed on patients with no proven mutation of RNU4ATAC and their blood relatives (19 samples total) by high throughput sequencing and genetic analysis of already collected deoxyribonucleic acid samples.

Altogether, such a study will allow a better understanding of the molecular mechanisms responsible for the Taybi-Linder syndrome and Taybi-Linder syndrome-like phenotypes as well as the pathophysiology of these devastating forms of microcephalic dwarfism.

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Conditions studied

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with a Taybi-Linder or Taybi-Linder like syndrome and their blood relatives.

Inclusion criteria

  • foetus or young children diagnosed with a Taybi-Linder or Taybi-Linder like syndrome, with no RNU4ATAC mutation (index case)
  • aged 20 weeks pregnant to 18 years old
  • parents or sibling of the index cases, with informed consent for the analysis of both their DNA sample and the one of the index case.

Exclusion criteria

Exclusion Criteria:

  • no informed consent for the use of genetic samples for medical research
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
19 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Taybi-Linder index cases

    Taybi-Linder index cases who have already consented for the (re)use of their DNA samples for medical research.

    Genetic: Deoxyribonucleic acid analysis

  • Blood relatives of Taybi-Linder index cases

    Blood relatives of Taybi-Linder index cases who have already consented for the (re)use of their DNA samples for medical research.

    Genetic: Deoxyribonucleic acid analysis

Interventions

  • GeneticDeoxyribonucleic acid analysis

    This study consists in the high throughput exome sequencing and subsequent genetic bio-analysis of 19 deoxyribonucleic acid samples from 6 families, already collected and consented, including patients diagnosed with a Taybi-Linder syndrome and their relatives (parents and/or siblings).

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What researchers measure

Primary outcomes

  1. Identification of new variants involved in the Taybi-Linder syndrome

    A genetic high throughput exome capture sequencing of 19 deoxyribonucleic acid samples from patients diagnosed with a Taybi-Linder like syndrome and their blood relatives

    Time frame: Collection at time of diagnosis = less than one day

06

Study locations

1 site
  • Service de Génétique Clinique, Groupement Hospitalier Est, Hospices Civils de Lyon
    Lyon, 69677, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03222947
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 19, 2017
Start date
Sep 2017 (estimated)
Primary completion
May 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jul 19, 2017

Study contacts

Audrey PUTOUX, MCU-PH
Contact
audrey.putoux@chu-lyon.fr
04 27 85 50 83 ext. +33
Charles EDERY, PU-PH
Contact
charles.edery@chu-lyon.fr
04 27 85 55 73 ext. +33

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 status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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