NCT01256606CompletedNot Applicable
Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy
Roche Sequencing Solutions6 sites in 1 country4,000 target enrollmentStarted: August 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4,000
- Locations
- 6
- Primary Endpoint
- Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
Study Overview
Brief Summary
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is 18yrs or older
- •Subject has a singleton pregnancy
- •Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
- •Subject is able to provide consent
Exclusion Criteria
- •Subject is pregnant with more than one fetus
- •Subject (mother) has known aneuploidy
- •Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
- •Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.
Outcomes
Primary Outcomes
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
Time Frame: 24 months
Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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