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

Sponsor
Quest Diagnostics-Nichols Insitute (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04935138
Collaborator
Illumina, Inc. (Industry)
350
1
12
29.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: cfDNA analysis

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. microarray analysis of products of conception (POC) [7 days]

    chromosome anomalies

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quest Diagnostics San Juan Capistrano California United States 92675

Sponsors and Collaborators

  • Quest Diagnostics-Nichols Insitute
  • Illumina, Inc.

Investigators

  • Principal Investigator: Pranoot X Tanpaiboon, MD, Quest Diagnostics-Nichols Insitute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Quest Diagnostics-Nichols Insitute
ClinicalTrials.gov Identifier:
NCT04935138
Other Study ID Numbers:
  • CD20-011
First Posted:
Jun 22, 2021
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022