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

Pregnancy Clinical Trial

Official title:

Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620110
• Other study ID #: NIPT-C00-002
• Status: Completed
• Start date: May 21, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Illumina, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective, multi-center specimen collection study; each subject's treatment, management, or medical care will not be determined by the study protocol.

Women 18 years of age or older with a viable pregnancy of at least 10 weeks gestation will be enrolled. A whole blood sample will be collected from each subject.

Subjects will be followed until data or specimens used to establish the clinical reference standard are collected, and pregnancy outcome and birth information is collected (if applicable). If cytogenetic test results from standard-of-care procedures are not available and pregnancies end in live births, a neonatal buccal swab specimen will be collected.

Maternal specimens will be processed to plasma and stored for future testing with an investigational NIPT(s). There will be no investigational NIPT results nor centralized CMA LDT results generated under this protocol.

Cytogenetic results from standard-of-care procedures and microarray results will be used to classify the clinical status of subjects according to the clinical reference standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2209
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	United Women's Clinical Research-Greensboro	Greensboro	North Carolina
United States	Unified Women's Clinical Research - Hagerstown	Hagerstown	Maryland
United States	Jackson Clinic	Jackson	Tennessee
United States	Unified Women's Clinical Research - Morehead City	Morehead City	North Carolina
United States	The Group for Women	Norfolk	Virginia
United States	Valley Perinatal Services	Phoenix	Arizona
United States	Unified Women's Clinical Research - Raleigh	Raleigh	North Carolina
United States	Unified Women's Clinical Research - Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Illumina, Inc.	Agility Clinical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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