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TWIST Human Gene and Cleft Lips and Palates

Primary Purpose

Cleft Lip

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
None: molecular genetics diagnosis procedure only
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cleft Lip focused on measuring Facial clefting, twist, craniofacial development genes, Human cleft lip and palate, cleft lip and palate

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged from 1 month to 18 years: Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so Healthcare insurance holders Display facial clefting Grown patients over 18 years of age: Agree to enrollment Display facial clefting Healthcare insurance holders Exclusion Criteria: Patients declining enrollment Patients without healthcare insurance

Sites / Locations

  • Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
  • Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Outcomes

Primary Outcome Measures

to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development

Secondary Outcome Measures

to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes

Full Information

First Posted
September 13, 2005
Last Updated
March 26, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00213889
Brief Title
TWIST Human Gene and Cleft Lips and Palates
Official Title
TWIST Human Gene and Cleft Lips and Palates
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
February 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

5. Study Description

Brief Summary
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip
Keywords
Facial clefting, twist, craniofacial development genes, Human cleft lip and palate, cleft lip and palate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
None: molecular genetics diagnosis procedure only
Intervention Description
None: molecular genetics diagnosis procedure only
Primary Outcome Measure Information:
Title
to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development
Time Frame
Not relevant
Secondary Outcome Measure Information:
Title
to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes
Time Frame
Not relevant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged from 1 month to 18 years: Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so Healthcare insurance holders Display facial clefting Grown patients over 18 years of age: Agree to enrollment Display facial clefting Healthcare insurance holders Exclusion Criteria: Patients declining enrollment Patients without healthcare insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal TSCHILL, MD
Organizational Affiliation
Laboratoire de Génétique Molécules des Eucaryotes (LGME)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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