Feasibility of Obstetric and Cancer Universal Screening
Weill Medical College of Cornell University
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.
Description
The purpose of this study is to prospectively offer obstetric patients combined hereditary cancer screening (HCS) and obstetric carrier screening (OCS) to see if patients decide they want HCS in addition to their OCS. Preconception and pregnancy represent a unique window of opportunity for women to engage and interact with the healthcare system. With the proposed trial, the investigators aim to change the paradigm of obstetrical-related genetic testing to include potentially life-saving HCS. Approximately 25% of the general population in the U.S. meets established criteria to recommend geneti…
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
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 auto…
Interventions
- GeneticMyRisk 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.
Locations (5)
- Reproductive MedicineBrooklyn, New York
- NewYork-Presbyterian Weill Cornell MedicineBrooklyn, New York
- Reproductive MedicineNew York, New York
- Weill Cornell MedicineNew York, New York
- NewYork-Presbyterian Weill Cornell Medicine QueensQueens, New York