TWIST Human Gene and Cleft Lips and Palates

Cleft Lip Clinical Trial

Official title:

TWIST Human Gene and Cleft Lips and Palates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00213889
• Other study ID #: 2602
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 26, 2015
• Start date: February 2003
• Est. completion date: July 2008

Study information

• Verified date: March 2015
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cleft Lip

Intervention

Other:
• None: molecular genetics diagnosis procedure only
None: molecular genetics diagnosis procedure only

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development		Not relevant	No
Secondary	to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes		Not relevant	No