NCT03065686

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

7 years

First QC Date

February 23, 2017

Last Update Submit

February 9, 2023

Conditions

Cleft Lip and Palate

Keywords

Cleft Lip and PalateCL/PWES

Outcome Measures

Primary Outcomes (1)

  • Identification of genetic factors

    Identification of genetic factors implicated in orofacial cleft using whole exome sequencing (WES).

    Day 1

Study Arms (1)

Identification of genetic factors

EXPERIMENTAL

Clinical questionnaire and analysis of genetic data obtained by exome high-throughput sequencing

Genetic: identification of genetic factors

Interventions

identification of genetic factorsGENETIC

Clinical questionnaire and analysis of genetic data obtained by exome high-throughput sequencing

Identification of genetic factors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bénédicte DEMEER, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bénédicte DEMEER, MD

CONTACT

+33 3 22 08 75 81demeer.benedicte@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

February 28, 2017

Study Start

November 30, 2016

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

FR(1)