Status:

RECRUITING

Genomic Sequencing in Anatomically Normal Fetuses

Lead Sponsor:

University of California, San Francisco

Conditions:

Pregnant Individuals Requesting Standard Microarray

Eligibility:

All Genders

18-64 years

Phase:

NA

Brief Summary

This cohort study will examine the clinical utility of genomic sequencing (GS) in patients undergoing prenatal diagnostic procedures (chorionic villus sampling or amniocentesis) for routine indication...

Detailed Description

Individuals who request prenatal diagnostic testing with standard chromosomal microarray will be offered GS as an option to assess for additional disease risk. The GS will be limited to evaluation of ...

Eligibility Criteria

Inclusion

  • Pregnant patients who are:
  • Pregnant with a structurally normal fetus (singleton or multiple gestation)
  • Planning to undergo prenatal diagnosis by either chorionic villus sampling or amniocentesis with chromosome microarray analysis for routine indications
  • Planning, or have already completed expanded carrier screening

Exclusion

  • Pregnant patients who:
  • Decline prenatal diagnostic testing
  • Are pregnant and their fetus has a known anomaly
  • Declined chromosomal microarray analysis of expanded carrier screening

Key Trial Info

Start Date :

January 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2030

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT06211348

Start Date

January 1 2024

End Date

January 1 2030

Last Update

April 6 2025

Active Locations (1)

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University of California, San Francisco

San Francisco, California, United States, 94143