Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07195071
Status
Recruiting
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Conditions

  • Hereditary Cancer Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Natera empower comprehensive hereditary cancer panel — DEVICE
    Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers
  • Obstetrical carrier screening — DEVICE
    Obstetrical carrier screening for genetic conditions

Study Details

The investigators hypothesize that preconception and pregnancy may be a feasible and effective time to offer inherited cancer risk screening. This study will assess interest in cancer genetic testing among patients receiving routine prenatal care or preconception care. The goal is to evaluate the acceptability of hereditary cancer testing when offered alongside standard prenatal genetic screening. The study will also explore whether universal screening in this population could support early cancer prevention

Key Dates

Start date
Feb 12, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Arm A: Hereditary cancer testing
    Hereditary Cancer screenings testing and Obstetric Cancer Screening
  • Active Comparator: Arm B: No hereditary caner testing
    Obstetric Cancer screening test only

Primary Outcome Measure

Percentage of Participants Who Complete Both HCS and OCS [ Time Frame: Approximately at the end of recruitment, expected at 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Jessica Giordano
[email protected]
212-305-7250
Reena M Vattakalam
[email protected]
212-342-6895
Shayan Dioun, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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