Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny | NCT01460316

Studies
Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny

NCT01460316

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jan 27, 2016Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Conotruncal Cardiac Defects

Interventions

Bood sampling for biochemicals and genetic analysis

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

May 2015Actual

Completion Date

Not provided

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 25, 2011

First Posted Date

Oct 26, 2011Estimated

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

Jan 26, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

FEILLET François, Professor, M.D. Ph.D, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Name	Class
Centre Hospitalier Universitaire de Besancon	OTHER
University Hospital, Strasbourg, France	OTHER
Centre Hospitalier Universitaire Dijon	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conotruncal cardiac defects patients			Biological: Bood sampling for biochemicals and genetic analysis
Mothers of patients			Biological: Bood sampling for biochemicals and genetic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bood sampling for biochemicals and genetic analysis	Biological	There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Conotruncal cardiac defects patients and theirs mothers
Weight: > 3750 g

Exclusion Criteria:

Syndromic conotruncal cardiac defects
22q11 deletion Holder's
Patients whose mother's took anti-folates before and during first pregnancy semester

Accepts Healthy Volunteers

Yes

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

Conotruncal cardiac defects population and theirs mothers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François FEILLET, MD-PHD	CHU de Nancy- Hôpital Brabois Enfants	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Cardiologie Pédiatrique, CHU Brabois Enfants		Vandœuvre-lès-Nancy		54500	France

Condition Browse Module

MeSH Terms

ID	Term
C535464	Conotruncal cardiac defects

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided