Clinical trial NCT03620110: A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Agility Clinical, Inc.
First posted: 2018-08-08
Enrollment: 2209
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Absence of chromosomal aneuploidy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Perinatal Services
state: Arizona
city: Hagerstown
country: United States
facility: Unified Women's Clinical Research - Hagerstown
state: Maryland
city: Greensboro
country: United States
facility: United Women's Clinical Research-Greensboro
state: North Carolina
city: Morehead City
country: United States
facility: Unified Women's Clinical Research - Morehead City
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research - Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research - Lyndhurst Clinical Research
state: North Carolina
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
Study officials:
affiliation: Columbia University
name: Ronald Wapner, MD
role: PRINCIPAL_INVESTIGATOR
References: