Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

November 30, 2023 updated by: Quest Diagnostics-Nichols Insitute
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Juan Capistrano, California, United States, 92675
        • Quest Diagnostics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Previously pregnant women that have recently miscarried.

Description

Inclusion Criteria:

  • 5-20 weeks of gestation by ultrasound
  • Miscarriage diagnosed by ultrasound
  • Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion Criteria:

  • Maternal age < 18 years
  • No visible pregnancy tissue on ultrasound
  • Multiple fetal gestation (> than singleton)
  • Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
  • No microarray testing is planned on the product of conception
  • Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
  • Patient unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microarray analysis of products of conception (POC)
Time Frame: 7 days
chromosome anomalies
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quest Diagnostics-Nichols Insitute

Collaborators

Illumina, Inc.

Investigators

  • Principal Investigator: Pranoot X Tanpaiboon, MD, Quest Diagnostics-Nichols Insitute
  • Principal Investigator: Karen E Racicot, PhD, Quest Diagnostics-Nichols Insitute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD20-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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