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NCT00314691 Clinical Trial

Development of New Prenatal Diagnostic Tests From Maternal Blood

Hereditary Diseases Clinical Trial

Official title:
Development of New Prenatal Diagnostic Tests From Maternal Blood

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00314691
Other study ID # 3612
Secondary ID
Status Terminated
Phase N/A
First received April 12, 2006
Last updated July 27, 2011
Start date April 2006
Est. completion date September 2006

Study information
Verified date July 2007
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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...

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Genetic:
• Blood samples

Locations
Country Name City State
France Sihcus-Cmco Strasbourg Schiltigheim

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of fetal gender and genotype determination out of maternal blood
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