A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

NCT03620110 | Completed

• 1 other identifier: NIPT-C00-002
• Study Type: observational
• Target: 2,209
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Absence of chromosomal aneuploidy

  Collect up to 2,200 maternal blood samples with the number of affected samples with chromosomal aneuploidy less than 0.5% based on clinical data from standard of care invasive procedure, neonate physical exam or chromosomal microarray result from the neonate buccal swab specimen.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women 18 years of age or older, at any risk of fetal chromosomal anomaly, with a viable pregnancy of at least 10 weeks gestation

You may qualify if:

• Has a viable pregnancy of at least 10 weeks, 0 days gestation at the time of maternal specimen collection (singleton or multiple pregnancy acceptable),
• Be 18 years of age or older at enrollment, and
• Is willing and able to provide documentation of informed consent.

You may not qualify if:

• Has a prior NIPT result from the current pregnancy,
• Had an invasive prenatal diagnostic procedure (eg, CVS, amniocentesis) in the current pregnancy before maternal specimen collection,
• Has a history of transplant or malignancy,
• Had a transfusion of blood or blood components up to 8 weeks before maternal specimen collection,
• Had preimplantation genetic screening for the current pregnancy (for in vitro fertilization patients only), or
• Has already participated in the study (enrolled previously)

Sponsors & Collaborators

• Illumina, Inc.: lead
• Agility Clinical, Inc.: collaborator

Study Sites (8)

Valley Perinatal Services

Phoenix, Arizona, 85004, United States

Location

Unified Women's Clinical Research - Hagerstown

Hagerstown, Maryland, 21740, United States

Location

United Women's Clinical Research-Greensboro

Greensboro, North Carolina, 27408, United States

Location

Unified Women's Clinical Research - Morehead City

Morehead City, North Carolina, 28557, United States

Location

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, 27607, United States

Location

Unified Women's Clinical Research - Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human blood specimens will be spun to plasma and stored at -80C freezers

Study Officials

• Ronald Wapner, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 8, 2018
• Study Start: May 21, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)