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TWIST Human Gene and Cleft Lips and Palates

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213889
First Posted: September 21, 2005
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

Condition Intervention
Cleft Lip Other: None: molecular genetics diagnosis procedure only

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: TWIST Human Gene and Cleft Lips and Palates

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 Measures:
  • to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes [ Time Frame: Not relevant ]

Enrollment: 45
Study Start Date: February 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: None: molecular genetics diagnosis procedure only
    None: molecular genetics diagnosis procedure only
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213889


Locations
France
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, 67091
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
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pascal TSCHILL, MD Laboratoire de Génétique Molécules des Eucaryotes (LGME)
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213889     History of Changes
Other Study ID Numbers: 2602
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Strasbourg, France:
Facial clefting
twist
craniofacial development genes
Human cleft lip and palate
cleft lip and palate

Additional relevant MeSH terms:
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities