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Recruiting NCT03065686

Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing

No phase Interventional Cleft Lip and Palate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: identification of genetic factors.
Who it may be relevant to
Registry conditions: Cleft Lip and Palate. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing GENEPIC

Overview

Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting

Detailed description

Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting. Moreover, the efficiency of Whole Exome Sequencing -WES- was proven. The efficiency of WES was proven by the identification of the genes causing Freeman Sheldon and Miller's syndrome, followed by several others. In the Picardy region, management and follow-up of orofacial cleft patients are well-organised by a multidisciplinary team in the university hospital of Amiens. The investigators therefore decided to perform whole exome sequencing (WES) on precisely phenotyped non-syndromic CL/P patients followed in our center.

Interventions

  • Genetic identification of genetic factors
    Clinical questionnaire and analysis of genetic data obtained by exome high-throughput sequencing

Primary outcome measures

  • Identification of genetic factors [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Subject with a NSCL/P or CL/P of unknown etiology,
  • national health care insurance holders

Exclusion criteria

  • Subject with a CL/P of known etiology,
  • Subject with a NSCL/P and an IRF6 mutation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT03065686 · PI2015_843_0016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗