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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04935138
Recruitment Status : Enrolling by invitation
First Posted : June 22, 2021
Last Update Posted : February 28, 2022
Sponsor:
Collaborator:
Illumina, Inc.
Information provided by (Responsible Party):
Quest Diagnostics-Nichols Insitute

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
Early Pregnancy Loss Genetic: cfDNA analysis

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Study Type : Observational
Estimated 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 : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy


Intervention Details:
  • Genetic: cfDNA analysis
    sequencing data from cfDNA analysis


Primary Outcome Measures :
  1. microarray analysis of products of conception (POC) [ Time Frame: 7 days ]
    chromosome anomalies


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Previously pregnant women that have recently miscarried.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04935138


Locations
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United States, California
Quest Diagnostics
San Juan Capistrano, California, United States, 92675
Sponsors and Collaborators
Quest Diagnostics-Nichols Insitute
Illumina, Inc.
Investigators
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Principal Investigator: Pranoot X Tanpaiboon, MD Quest Diagnostics-Nichols Insitute
Publications:
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Responsible Party: Quest Diagnostics-Nichols Insitute
ClinicalTrials.gov Identifier: NCT04935138    
Other Study ID Numbers: CD20-011
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Chromosome Disorders
Chromosome Aberrations
Congenital Abnormalities
Pregnancy Complications
Death
Pathologic Processes
Genetic Diseases, Inborn