Development of a NIPTT for Detecting Copy Number Variations
NCT ID: NCT04774640
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
9 participants
OBSERVATIONAL
2014-05-29
2018-04-30
Brief Summary
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Detailed Description
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This study will evaluate whether the test methods being developed for the detection of fetal chromosomal abnormalities of interest in maternal whole blood samples can be used in clinical practice.
Enrollment of study subjects will be done in two phases - an initial pilot study phase to collect samples for research and development activities, followed by a larger single-blinded sample collection phase for NIPT evaluation. For both phases, study subjects will be enrolled in a prospective manner until the predetermined sample size is attained. Each study subject will be asked to provide one 20mL blood sample.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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MaterniT GENOME
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
89 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Sequenom, Inc.
INDUSTRY
Responsible Party
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Locations
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Columbia University
New York, New York, United States
Countries
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Other Identifiers
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SQNM-T21-306
Identifier Type: -
Identifier Source: org_study_id
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