Development of New Prenatal Diagnostic Tests From Maternal Blood

This study has been terminated.

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00314691

Purpose

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...

Condition	Intervention
Hereditary Diseases	Gene Transfer: Blood samples

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Development of New Prenatal Diagnostic Tests From Maternal Blood

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

Feasibility of fetal gender and genotype determination out of maternal blood

Enrollment:	10
Study Start Date:	April 2006
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314691

Locations

France, Schiltigheim
SIHCUS-CMCO
STRASBOURG, Schiltigheim, France, 67300

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Romain FAVRE, MD

SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE

More Information

Study ID Numbers:	3612
Study First Received:	April 12, 2006
Last Updated:	July 3, 2007
ClinicalTrials.gov Identifier:	NCT00314691
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:

fetal DNA
prenatal diagnosis
maternal plasma
Diagnostic potential of cell-free fetal DNA circulating in maternal blood

Study placed in the following topic categories:

Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on January 16, 2009