TWIST Human Gene and Cleft Lips and Palates

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Terminated	Cleft Lip	University Hospital, Strasbourg, France Other	September 13, 2005	June 25, 2010	June 2010

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic	N/A	100	February 2003	-

Facility	Address	Contact	Phone	Email	Status
Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg 67091 France	-	-	-	-
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg 67098 France	-	-	-	-
Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg 67091 France	-	-	-	-
Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg 67098 France	-	-	-	-

Type	Intervention	Description
Other	None: molecular genetics diagnosis procedure only	None: molecular genetics diagnosis procedure only

Type	Measure	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

TWIST Human Gene and Cleft Lips and Palates

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Both	-	N/A	No

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