Status:
TERMINATED
Development of a NIPTT for Detecting Copy Number Variations
Lead Sponsor:
Sequenom, Inc.
Collaborating Sponsors:
Columbia University
Conditions:
Copy Number Variations
Eligibility:
FEMALE
18-89 years
Brief Summary
To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal...
Detailed Description
This is a single center specimen collection study. Eligible subjects from across the USA will be referred to the single center for participation. This study will evaluate whether the test methods bei...
Eligibility Criteria
Inclusion
- Subject is female
- Subject is 18 years of age or older
- Subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation
- Subject provides a signed and dated informed consent
- Subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other CNVs) as determined by microarray analysis of fetal cellular material obtained by IP
Exclusion
- Subject has experienced fetal demise in the current pregnancy
Key Trial Info
Start Date :
May 29 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04774640
Start Date
May 29 2014
End Date
April 30 2018
Last Update
August 9 2023
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032