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Completed No phase listed Observational

VAlidation of a Lower Cost aneUploidy scrEen

ClinicalTrials.gov ID: NCT03087357

Public ClinicalTrials.gov record NCT03087357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 1:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The VALUE Study - Women & Infants as the Coordinating Center

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will document the detection rate and false positive rate as well as failure rate of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and implemented in an academic laboratory with limited molecular testing experience. Testing will be performed on samples from a general risk pregnancy population, with additional high-risk cases added to improve confidence in the detection rate. Additional characteristics of this non-NGS test such as turn-around time, costs (equipment, training, per test), results reporting, fetal sex, fetal fraction, and quality measures will also be examined.

Study identification

NCT ID
NCT03087357
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
2,443 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 9, 2017
Primary completion
Nov 18, 2019
Completion
Sep 30, 2020
Last update posted
Sep 21, 2022

2017 – 2020

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Center for Fetal Medicine Los Angeles California 90048
University of Colorado Aurora Colorado 80045
Bridgeport Hospital Bridgeport Connecticut 06610
University of South Florida Tampa Florida 33606
Northwestern Memorial Medical Center Chicago Illinois 60611
Brigham and Women's Hospital Boston Massachusetts 02110
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
South Shore Hospital South Weymouth Massachusetts 02190
Womens Health Care Group Oaks Pennsylvania 19456
Magee Womens Hospital Pittsburgh Pennsylvania 15213
Women & Infants Hospital of Rhode Island Providence Rhode Island 02905
University of Texas Houston Texas 77030
Swedish Medical Center Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03087357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2022 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03087357 live on ClinicalTrials.gov.

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