Genomic Sequencing in Anatomically Normal Fetuses

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06211348
Status
Recruiting

Conditions

  • Pregnant Individuals Requesting Standard Microarray

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Genomic Sequencing — DEVICE
    Individuals who request prenatal diagnostic testing with standard chromosomal microarray will be offered genomic sequencing (GS) as an option to assess for additional disease risk.

Study Details

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 indications other than a structural fetal anomaly.

Key Dates

Start date
Jan 1, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Genomic Sequencing

Primary Outcome Measure

Detection of pathogenic or likely pathogenic variants with genomic sequencing [ Time Frame: Up to 2 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Nuriye Sahin Hodoglugil, DrPH
Mary Norton, MD (PRINCIPAL_INVESTIGATOR)

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