Development of New Prenatal Diagnostic Tests From Maternal Blood

This study has been terminated.

(Leaving of the person responsible for the data collection)

Sponsor:

Information provided by:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT00314691

First received: April 12, 2006

Last updated: July 27, 2011

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2006

Last Updated Date

July 27, 2011

Start Date ^ICMJE

April 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Feasibility of fetal gender and genotype determination out of maternal blood

Original Primary Outcome Measures ^ICMJE

Feasability of fetal gender and genotype determination out of maternal blood

Change History

Complete list of historical versions of study NCT00314691 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Development of New Prenatal Diagnostic Tests From Maternal Blood

Official Title ^ICMJE

Development of New Prenatal Diagnostic Tests From Maternal Blood

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Hereditary Diseases

Intervention ^ICMJE

Genetic: Blood samples

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00314691

Other Study ID Numbers ^ICMJE

3612

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Romain FAVRE, MD

SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE

Information Provided By

University Hospital, Strasbourg, France

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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