Trial of Combined Obstetric Carrier Screening and Hereditary Cancer Screening

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07052266
Status
Recruiting
Apply to this trial

Conditions

  • Hereditary Cancer Syndromes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • MyRisk Hereditary Cancer Test — GENETIC
    Subjects that are planning to proceed with OCS and enrolled in the trial will be contacted by the genetics clinician (by telephone or in person, based on subject preference) to review the option for HCS in addition to OCS. The WCM genetics clinician will review the potential risks and benefits, possible findings, and implications of findings for HCS. The genetics clinician will follow WCM standards (outlined by the WCM Genetics and Personalized Cancer Prevention Program https://wcinyp.org/GPCP) for informed consent counseling on the potential risks/benefits of HCS. The counseling regarding OCS will have already been performed by the obstetrical team as part of the standard of care. The genetics clinician will review that OCS is being performed as part of the patient's standard of care prenatal visit and HCS is an additional component that is being performed as part of participation in this clinical trial.

Study Details

The investigators hypothesize that pregnancy and preconception care 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 or preconception/fertility care. The goal is to evaluate the acceptability of BRCA1/2 testing when offered alongside standard prenatal genetic screening. The study will also explore whether universal screening in this population could support early cancer prevention and be cost-effective, especially among underserved populations.

Key Dates

Start date
Sep 2, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Collection of HCS and OCS for patients receiving obstetrical-related care
    The first arm is for an obstetrical/prenatal (standard arm) setting
  • Experimental: Collection of HCS and OCS for patients receiving preconception/fertility care
    This second arm is at reproductive endocrinology and infertility clinics (preconception arm)

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian Weill Cornell MedicineBrooklynNew York11215
Denise Howard, MD, MPH
[email protected]
7183623260
Reproductive MedicineBrooklynNew York11201
Joshua D. Stewart, MD
[email protected]
6469623868
Reproductive MedicineNew YorkNew York10021
Alexis Melnick, MD
[email protected]
6469627650
Weill Cornell MedicineNew YorkNew York10065
Elise Barrow, MPH
[email protected]
6466976621
Steve Lopez, BA
[email protected]
9143127488
Melissa Frey, MD, MS (PRINCIPAL_INVESTIGATOR)
NewYork-Presbyterian Weill Cornell Medicine QueensQueensNew York11355
Julia Cron, MD, FACOG
[email protected]
6469622620

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By research site
NewYork-Presbyterian Weill Cornell Medicine· Brooklyn, NYReproductive Medicine· Brooklyn, NYReproductive Medicine· New York, NYWeill Cornell Medicine· New York, NYNewYork-Presbyterian Weill Cornell Medicine Queens· Queens, NY

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