Actively Recruiting
Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
Led by Columbia University · Updated on 2026-02-18
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
Natera, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the feasibility and acceptability of offering hereditary cancer risk screening alongside standard prenatal genetic testing in patients receiving routine prenatal or preconception care. The study aims to assess interest in genetic testing for inherited cancer risk and explore if universal screening during these periods can help support early cancer prevention. This is a prospective, interventional trial conducted at Columbia University-affiliated obstetrics clinics. Participants will meet with a clinician who will review options for combining hereditary cancer screening (HCS) with obstetrical carrier screening (OCS). Those interested will receive counseling on the benefits and risks of genetic testing, have blood drawn for both OCS and the Natera Empower Hereditary Cancer Panel for cancer screening, and may consult with a genetic counselor and financial representative. OCS results are reported per standard care, while HCS results are delivered by a genetic counselor with follow-up counseling and referrals as needed. Participants will complete surveys about their experience and decision regret at multiple time points, and demographic and clinical data will be securely stored. Those with mutations indicating clinical follow-up needs will be contacted 18 months later to check on follow-up completion. Interviews may also be conducted by phone. The primary outcome is the percentage of participants completing both screenings, with secondary outcomes including regret survey scores and use of cancer risk mitigation strategies. The study is expected to complete recruitment over approximately two years.
CONDITIONS
Brief Title
Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years
- Receiving obstetrical-related care at a Columbia University Medical Center-affiliated site
- Elected to undergo obstetrical carrier screening with a Columbia University-affiliated obstetrics provider
- Patients with prior obstetrical carrier screening planning to repeat screening are eligible
- Able to speak and read English or Spanish
You will not qualify if you...
- Previously completed a multigene hereditary cancer syndrome panel
- Have a hematologic cancer or hematologic pre-cancer
- History of an autologous bone marrow transplant
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to time of test results
Participants undergo obstetrical carrier screening and, if they choose, hereditary cancer screening with counseling and risk assessment.
1 visit for blood draw and counseling; additional consultation visits with a genetic counselor or financial representative if desired
Duration - 18 months after enrollment
Participants who have mutations indicating clinical follow-up are contacted at 18 months to assess completion of recommended medical follow-up.
1 telephone follow-up
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Jessica Giordano
R
Reena Vattakalam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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