Hereditary cancer screening offered during obstetrical carrier screening
Official title: Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
Run by Columbia University · NCT07195071 · Data updated 2026-11-12
This project will test offering hereditary cancer genetic testing to pregnant and preconception patients who are already getting obstetrical carrier screening to see if they want it and can complete testing alongside routine prenatal care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07195071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant or preconception patients aged 18–55 receiving obstetrical care at Columbia-affiliated clinics who have elected obstetrical carrier screening, can read/speak English or Spanish, and have not previously completed a multigene hereditary cancer panel.
✕Probably not a fit
Patients who previously completed a multigene hereditary cancer panel, have a hematologic cancer or pre-cancer, have had an autologous bone marrow transplant, or who do not receive care at the Columbia sites are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Clinicians in Columbia University–affiliated OBGYN clinics will offer concurrent hereditary cancer screening (HCS) to patients undergoing routine obstetrical carrier screening (OCS). Interested patients will receive counseling, a detailed personal and family history to generate a cancer risk assessment, and the option to proceed with the Natera Empower hereditary cancer panel at the time of the OCS blood draw. Results will be returned by a Columbia genetic counselor and follow standard-of-care post-test counseling and referrals as needed. The protocol includes English and Spanish counseling and is limited to patients seen at Columbia-affiliated enrollment sites.
Why it matters
Potential benefit: If successful, offering hereditary cancer screening during prenatal visits could identify individuals at increased cancer risk earlier and enable earlier prevention, surveillance, or family testing.
How similar studies have gone: Population-level hereditary cancer screening programs have shown promise for identifying at-risk individuals, but offering HCS specifically alongside prenatal carrier screening is relatively novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age: 18 years - 55 years * Patients receiving obstetrical-related care at a CUMC-affiliated enrollment site * Patients who have elected to undergo OCS with the CUMC-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 that have a hematologic cancer or hematologic pre-cancer * Patients who have a history of an autologous bone marrow transplant
Where it's running
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Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Shayan Dioun, MD — Columbia University
- Study coordinator: Jessica Giordano
- Email: jlg2197@cumc.columbia.edu
- Phone: 212-305-7250
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.