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

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

      • Strasbourg, France, 67091
        • Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67091
        • Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67098
        • Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67098
        • Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

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

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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