NCT06211348

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jan 2024Jan 2030

Study Start

First participant enrolled

January 1, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

January 8, 2024

Last Update Submit

April 6, 2026

Conditions

Pregnant Individuals Requesting Standard Microarray

Outcome Measures

Primary Outcomes (1)

  • Detection of pathogenic or likely pathogenic variants with genomic sequencing

    Proportion of positive genetic diagnosis among all pregnancies with anatomically normal fetuses

    Up to 2 months after enrollment

Study Arms (1)

Genomic Sequencing

EXPERIMENTAL
Device: Genomic Sequencing

Interventions

Genomic SequencingDEVICE

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.

Genomic Sequencing

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Study Officials

  • Mary Norton, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuriye Sahin Hodoglugil, DrPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)