Recruiting

Genomic Sequencing

Sponsor:

UCLA

Code:

NCT06211348

Conditions

Pregnant Individuals Requesting Standard Microarray

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Genomic Sequencing

Study Details

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 indications other than a structural fetal anomaly.

Conditions

Pregnant Individuals Requesting Standard Microarray

Study ID

NCT06211348

Start date

Jan 1, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

Pregnant patients who:

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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Genomic Sequencing

Interventions

Genomic Sequencing

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nuriye Sahin Hodoglugil, DrPH

415-353-3400Nuriye.Sahin-Hodoglugil@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Nuriye Sahin Hodoglugil, DrPH

Nuriye.Sahin-Hodoglugil@ucsf.edu

Principal Investigator:

Mary Norton, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-08.