- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213889
TWIST Human Gene and Cleft Lips and Palates
March 26, 2015 updated by: University Hospital, Strasbourg, France
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Strasbourg, France, 67091
- Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
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Strasbourg, France, 67091
- Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
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Strasbourg, France, 67098
- Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
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Strasbourg, France, 67098
- Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Not relevant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes
Time Frame: Not relevant
|
Not relevant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pascal TSCHILL, MD, Laboratoire de Génétique Molécules des Eucaryotes (LGME)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2602
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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