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Development of New Prenatal Diagnostic Tests From Maternal Blood

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ClinicalTrials.gov 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
Sponsor:
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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00314691


Locations
France
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

ClinicalTrials.gov Identifier: NCT00314691     History of Changes
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:
Genetic Diseases, Inborn