Recruiting

Cancer Genetic Testing

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07052266

Conditions

Hereditary Cancer Syndromes

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

MyRisk Hereditary Cancer Test

Study Details

Brief summary:

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.

Conditions

Hereditary Cancer Syndromes

Study ID

NCT07052266

Start date

Sep 2, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years - 55 years
  • Pregnant patients receiving obstetrical-related care or receiving preconception/fertility care at a WCM-affiliated enrollment site.
  • Patients who have elected to undergo OCS with the WCM-affiliated obstetrics provider
  • Patients with prior OCS but planned to repeat OCS are eligible
  • Patients can speak and read in English or Spanish

Exclusion Criteria:

  • Patients who have previously completed a multigene hereditary cancer syndrome panel
  • Patients who have a hematologic cancer or hematologic pre-cancer
  • Patients who have a history of an autologous bone marrow transplant

Study Design

Enrollment

550 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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)

Interventions

MyRisk Hereditary Cancer Test

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.

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 and Locations

Central contacts

Steve Lopez, BA

9143127488stl4013@med.cornell.edu

Ravi Sharaf, MD, MS

212-746-4014ras9030@med.cornell.edu

Locations

Reproductive Medicine

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Joshua D. Stewart, MD

6469623868jds9013@med.cornell.edu

Reproductive Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Alexis Melnick, MD

6469627650alm2036@med.cornell.edu

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Elise Barrow, MPH

6466976621ecb4001@med.cornell.edu

Steve Lopez, BA

9143127488stl4013@med.cornell.edu

Principal Investigator:

Melissa Frey, MD, MS

NewYork-Presbyterian Weill Cornell Medicine Queens

Recruiting

Queens, New York, United States, 11355

Contacts

Julia Cron, MD, FACOG

6469622620Jac4017@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • Genetic Testing
  • Carrier Screening
  • Prenatal Screening
  • Reproductive Genetic Testing
  • Feasibility Study
  • Universal Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-26.