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NCT04285814
Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood
trial testing Whole Fetal Cell (WFC) Testing in Copy Number Abnormality in 33 participants. Completed in 20 July 2023.
20 July 2023
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 33 |
| Start date | 1 September 2020 |
| Primary completion | 20 July 2023 |
| Estimated completion | 20 July 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Whole Fetal Cell (WFC) Testing
Conditions studied
- Copy Number Abnormality — all drugs for Copy Number Abnormality →
- Prenatal Diagnosis — all drugs for Prenatal Diagnosis →
- Genetic Disease — all drugs for Genetic Disease →
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.
Verify or expand the search:
- PubMed search for NCT04285814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04285814 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Columbia University
- Last refreshed: 29 January 2025
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