Combined carrier and hereditary cancer screening offered during pregnancy or preconception
Feasibility of Obstetric and Cancer Universal Screening
This project will test if pregnant and preconception patients will choose hereditary cancer genetic testing when it's offered alongside routine carrier screening.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 5 sites (Brooklyn, New York and 4 other locations) |
| Trial ID | NCT07052266 on ClinicalTrials.gov |
What this trial studies
The trial offers combined hereditary cancer screening using the MyRisk hereditary cancer test alongside standard obstetric carrier screening to patients receiving prenatal or preconception/fertility care at Weill Cornell Medicine–affiliated sites. Eligible participants aged 18–55 who elect carrier screening and who speak English or Spanish are invited to add hereditary cancer testing unless they have had a prior multigene hereditary cancer panel, hematologic cancer or precancer, or an autologous bone marrow transplant. The study will measure uptake, patient interest, acceptability, and demographic patterns of acceptance, and will explore implications for early prevention and cost-effectiveness. Data will be used to determine whether integrating hereditary cancer screening into obstetric workflows is feasible and could reduce under-recognition of inherited cancer risk.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18–55 receiving prenatal or preconception/fertility care at WCM-affiliated sites who have elected obstetric carrier screening and can read English or Spanish, and who have not already completed a multigene hereditary cancer panel.
Not a fit: Patients who already completed a multigene hereditary cancer panel, who have a hematologic cancer or hematologic precancer, or who have had an autologous bone marrow transplant are excluded and unlikely to benefit from this screening offer.
Why it matters
Potential benefit: If successful, offering hereditary cancer screening in obstetric care could identify people with inherited cancer risk earlier and allow preventive steps that reduce cancer-related harm.
How similar studies have performed: This is a relatively novel integration—prior work shows carrier screening is commonly accepted but few programs have formally added hereditary cancer screening into routine obstetric care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brooklyn, New York and 4 other locations
- Reproductive Medicine — Brooklyn, New York, United States (Recruiting)
- NewYork-Presbyterian Weill Cornell Medicine — Brooklyn, New York, United States (Not_yet_recruiting)
- Reproductive Medicine — New York, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- NewYork-Presbyterian Weill Cornell Medicine Queens — Queens, New York, United States (Recruiting)
Study contacts
- Principal investigator: Melissa Frey, MD, MS — Weill Medical College of Cornell University
- Study coordinator: Steve Lopez, BA
- Email: stl4013@med.cornell.edu
- Phone: 9143127488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.