Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

937 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2023-03-31

Brief Summary

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This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA in the maternal blood.

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Detailed Description

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First trimester screening is the current standard of care for pregnant women in the United States. Women with a high screening risk for trisomy then have invasive testing, which carries a risk of miscarriage, to definitively determine if the fetus has trisomy. Because of the high false negative rate of the first trimester screening, an unacceptable number of trisomic fetuses are not detected. Moreover, because of the high false positive rate, an unacceptable number of women undergo invasive follow up testing. Additional screening tests are needed that combine a high sensitivity, a low false positive rate, and minimal or no risk to the fetus.

Conditions

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Trisomy 13 Trisomy 18 Trisomy 21 Aneuploidy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women Blood Draw

Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw

Blood Draw

Intervention Type PROCEDURE

Blood will be drawn from the mother and father

Interventions

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Blood Draw

Blood will be drawn from the mother and father

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Singleton pregnancy
2. Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
3. Mother has a high or moderate risk for trisomy
4. Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure

Exclusion Criteria

1. Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
2. Egg donor used
3. Mother or father have known chromosomal abnormalities (including known balanced translocations)
4. Participation in the study in a previous pregnancy
5. Pregnancy is a result of IVF with pre-implantation genetic diagnosis

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Wapner, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Adventist Hinsdale Hospital

Hinsdale, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

NY Methodist Hospital

Brooklyn, New York, United States

Site Status