Development of New Prenatal Diagnostic Tests From Materna... | NCT00314691

Studies
Development of New Prenatal Diagnostic Tests From Maternal Blood

NCT00314691

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Jul 28, 2011Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Hereditary Diseases

Interventions

Blood samples

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

Jul 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Leaving of the person responsible for the data collection

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Apr 12, 2006

First Submission Date that Met QC Criteria

Apr 12, 2006

First Posted Date

Apr 14, 2006Estimated

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

Jul 27, 2011

Last Update Posted Date

Jul 28, 2011Estimated

Description Module

Brief Summary

After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy, B-Thalassaemia...

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

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Genetic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of fetal gender and genotype determination out of maternal blood

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mother and father-to-be both older than 18 years old
Mother and father-to-be affiliated to social security
Mother and father-to-be have good understanding of the protocol
Pregnancy of the mother-to-be attested

Exclusion Criteria:

Mother and father-to-be are younger than 18 years old
Mother and/or father-to be refusing to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romain FAVRE, MD	SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sihcus-Cmco		Strasbourg	Schiltigheim	67300	France

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided