Back to resultsDevelopment of New Prenatal Diagnostic Tests From Maternal Blood
Primary Purpose
Hereditary Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Hereditary Diseases focused on measuring fetal DNA, prenatal diagnosis, maternal plasma, Diagnostic potential of cell-free fetal DNA circulating in maternal blood
Eligibility 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
Sites / Locations
- Sihcus-Cmco
Outcomes
Primary Outcome Measures
Feasibility of fetal gender and genotype determination out of maternal blood
Secondary Outcome Measures
Full Information
NCT ID
NCT00314691
First Posted
April 12, 2006
Last Updated
July 27, 2011
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00314691
Brief Title
Development of New Prenatal Diagnostic Tests From Maternal Blood
Official Title
Development of New Prenatal Diagnostic Tests From Maternal Blood
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
Leaving of the person responsible for the data collection
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
5. Study Description
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...
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Diseases
Keywords
fetal DNA, prenatal diagnosis, maternal plasma, Diagnostic potential of cell-free fetal DNA circulating in maternal blood
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Feasibility of fetal gender and genotype determination out of maternal blood
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain FAVRE, MD
Organizational Affiliation
SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sihcus-Cmco
City
Strasbourg
State/Province
Schiltigheim
ZIP/Postal Code
67300
Country
France
12. IPD Sharing Statement
Learn more about this trial
Development of New Prenatal Diagnostic Tests From Maternal Blood
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