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Development of New Prenatal Diagnostic Tests From Maternal Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314691
Recruitment Status : Terminated (Leaving of the person responsible for the data collection)
First Posted : April 14, 2006
Last Update Posted : July 28, 2011
Information provided by:
University Hospital, Strasbourg, France

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...

Condition or disease Intervention/treatment Phase
Hereditary Diseases Genetic: Blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of New Prenatal Diagnostic Tests From Maternal Blood
Study Start Date : April 2006
Study Completion Date : September 2006

Primary Outcome Measures :
  1. Feasibility of fetal gender and genotype determination out of maternal blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314691

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Strasbourg, Schiltigheim, France, 67300
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Principal Investigator: Romain FAVRE, MD SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE

Layout table for additonal information Identifier: NCT00314691    
Other Study ID Numbers: 3612
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2007
Keywords provided by University Hospital, Strasbourg, France:
fetal DNA
prenatal diagnosis
maternal plasma
Diagnostic potential of cell-free fetal DNA circulating in maternal blood
Additional relevant MeSH terms:
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Genetic Diseases, Inborn