Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03087357 · ClinicalTrials.gov registry record
VAlidation of a Lower Cost aneUploidy scrEen
A clinical trial, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- 2,443
- Enrollment target
NCT03087357: Completed study, sponsored by Women and Infants Hospital of Rhode Island.
NCT03087357 is a clinical trial that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 2,443 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03087357 has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- 2,443 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The cfDNA test detection rate for Down syndrome will utilize both the general population (low risk) enrollment (2,400 pregnancies) as well as the high risk enrollment (250 pregnancies, all confirmed trisomy 21/18/13) and be defined as TP/(TP+FN). All low risk women with a cfDNA test positive for trisomy 21 will have comprehensive diagnostic follow-up as will all high risk women, assuring that all affected pregnancies in these two groups will have karyotype confirmation. The true positive (TP) Sm
Interventions
- OTHER SmartNIPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,443 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2020-10-01 |
What the finished NCT03087357 record still lists
NCT03087357 is an observational study that tracks outcomes without assigning an intervention. Its 2,443 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which SmartNIPT is the first listed.
NCT03087357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03087357 about?
NCT03087357 is a clinical study titled "VAlidation of a Lower Cost aneUploidy scrEen". 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 ...
What is the current status of trial NCT03087357?
This trial is currently completed. The enrollment target is 2,443 participants. The study started on 2017-10-10. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT03087357?
The interventions under investigation include: SmartNIPT (OTHER).
Who is sponsoring clinical trial NCT03087357?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06898593 · 2,448 participants · NA
Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients
- NCT06128304 · 2,436 participants · NA
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
- NCT06676904 · 2,433 participants · NA
Neonatal Platelet Transfusion Threshold Trial
- NCT05345951 · 2,425 participants · NA
Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI