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NCT04285814

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

Completed Last updated 29 January 2025
What this trial tests

trial testing Whole Fetal Cell (WFC) Testing in Copy Number Abnormality in 33 participants. Completed in 20 July 2023.

Timeline
1 September 2020
Primary endpoint
20 July 2023
20 July 2023

Quick facts

Lead sponsorColumbia University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date1 September 2020
Primary completion20 July 2023
Estimated completion20 July 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

18 and older, female only, with Copy Number Abnormality or Prenatal Diagnosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Columbia University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04285814.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing