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NCT04285814 · ClinicalTrials.gov registry record

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

A clinical trial of Genetic Disease and Prenatal Diagnosis, sponsored by Columbia University.

Completed
Registry status
33
Enrollment target
2
Study locations

NCT04285814 is a study of Genetic Disease and Prenatal Diagnosis that has completed, run by Columbia University. The registered enrollment target is 33 participants, below the 2,560-participant average among 30 other Genetic Disease trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04285814, a study of Genetic Disease and Prenatal Diagnosis, has completed, sponsored by Columbia University.

COMPLETED
Registry status
33 participants
Enrollment target
2
Study locations

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.

Interventions

  • DIAGNOSTIC_TEST Whole Fetal Cell (WFC) Testing

Study Locations (2)

New York

  • Columbia University - New York

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2020-09-01
Est. Completion 2023-07-20

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT04285814

The ClinicalTrials.gov registry entry for NCT04285814 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,560-participant average among 30 other Genetic Disease trials with a reported enrollment target (99% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Genetic Disease appearing as the primary indexed condition, and to 1 intervention - of which Whole Fetal Cell (WFC) Testing is the first listed.

NCT04285814 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Texas.

Frequently Asked Questions

What is clinical trial NCT04285814 about?

NCT04285814 is a clinical study titled "Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood". 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 c...

What is the current status of trial NCT04285814?

This trial is currently completed. The enrollment target is 33 participants. The study started on 2020-09-01. Estimated completion is 2023-07-20.

What conditions does trial NCT04285814 study?

This clinical trial studies the following conditions: Genetic Disease, Prenatal Diagnosis, Copy Number Abnormality.

What interventions are being tested in trial NCT04285814?

The interventions under investigation include: Whole Fetal Cell (WFC) Testing (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04285814?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04285814 being conducted?

This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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