TWIST Human Gene and Cleft Lips and Palates

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213889
First received: September 13, 2005
Last updated: June 25, 2010
Last verified: June 2010
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2003
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: None: molecular genetics diagnosis procedure only
    None: molecular genetics diagnosis procedure only
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213889

Locations
France
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
Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
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

No publications provided

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint de la DRCI, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213889     History of Changes
Other Study ID Numbers: 2602
Study First Received: September 13, 2005
Last Updated: June 25, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014