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Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood

NCT04285814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2025-01-29

No results posted yet for this study

Summary

Amniocentesis (amnio) and chorionic villus sampling (CVS) can reliably detect many smaller DNA/genetic abnormalities that cannot be reliably diagnosed by cell-free noninvasive prenatal testing (NIPT) that is in widespread use. The investigators present evidence that a cell-based form of NIPT, here called Single Fetal Cell (SFC) testing, using a blood sample from the mother can detect most or all of the genetic abnormalities that are detected using amnio or CVS. This study proposes to compare the effectiveness of SFC testing in detecting abnormalities already detected by amnio or CVS in women already undergoing these tests as part of their clinical care because of fetal ultrasound abnormalities.

Conditions

Interventions

DIAGNOSTIC_TEST

Whole Fetal Cell (WFC) Testing

Performing WFC testing on blood specimens.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Ronald Wapner, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285814 on ClinicalTrials.gov