TWIST Human Gene and Cleft Lips and Palates | NCT00213889

Studies
TWIST Human Gene and Cleft Lips and Palates

NCT00213889

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Mar 27, 2015Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Cleft Lip

Interventions

None: molecular genetics diagnosis procedure only

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None: molecular genetics diagnosis procedure only	Other	None: molecular genetics diagnosis procedure only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development		Not relevant

Secondary Outcomes

Measure	Description	Time Frame
to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes		Not relevant

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal TSCHILL, MD	Laboratoire de Génétique Molécules des Eucaryotes (LGME)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip
D000168	Acrocephalosyndactylia

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided