Clinical trial · Interventional
Trial of Combined Obstetric Carrier Screening and Hereditary Cancer Screening
Feasibility of Obstetric and Cancer Universal Screening
NCT07052266CI-TRIAL-00099684FOCUSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Cancer Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyRisk Hereditary Cancer Test | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Collection of HCS and OCS for patients receiving obstetrical-related care
- description
- The first arm is for an obstetrical/prenatal (standard arm) setting
- interventionNames
- Genetic: MyRisk Hereditary Cancer Test
- type
- EXPERIMENTAL
- label
- Collection of HCS and OCS for patients receiving preconception/fertility care
- description
- This second arm is at reproductive endocrinology and infertility clinics (preconception arm)
- interventionNames
- Genetic: MyRisk Hereditary Cancer Test
Primary outcomes (1)
- measure
- Percentage of Participants Who Complete Both HCS and OCS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (20)
- BACKGROUNDPalinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research. Adm Policy Ment Health. 2015 Sep;42(5):533-44. doi: 10.1007/s10488-013-0528-y. PMID 24193818
- BACKGROUNDKaphingst KA, Bather JR, Daly BM, Chavez-Yenter D, Vega A, Kohlmann WK. Interest in Cancer Predisposition Testing and Carrier Screening Offered as Part of Routine Healthcare Among an Ethnically Diverse Sample of Young Women. Front Genet. 2022 Apr 14;13:866062. doi: 10.3389/fgene.2022.866062. eCollection 2022. PMID 35495140
- BACKGROUNDDioun SM, Perez LR, Prabhu M, Brewer JT, Ahsan MD, Hou JY, Sharaf RN, Wright JD, Frey MK. Cost-effectiveness of BRCA1 testing at time of obstetrical prenatal carrier screening for cancer prevention. Am J Obstet Gynecol. 2024 Sep;231(3):330.e1-330.e14. doi: 10.1016/j.ajog.2024.04.014. Epub 2024 Apr 14. PMID 38621481
- BACKGROUNDGrant BJ, Chandler I, Son M, Dioun S, Mcdougale A, Sharaf RN, Frey MK. Pregnancy: an underutilized window of opportunity for genetic cancer risk assessment. Am J Obstet Gynecol. 2025 Jan;232(1):e11-e13. doi: 10.1016/j.ajog.2024.09.100. Epub 2024 Sep 19. No abstract available. PMID 39306315
- BACKGROUNDZhong L, Bather JR, Daly BM, Kohlmann WK, Goodman MS, Rothwell E, Kaphingst KA. Investigation of interest in and timing preference for cancer predisposition testing and expanded carrier screening among women of reproductive age. PEC Innov. 2023 Jan 24;2:100128. doi: 10.1016/j.pecinn.2023.100128. eCollection 2023 Dec. PMID 37214524
- BACKGROUNDEdwards JG, Feldman G, Goldberg J, Gregg AR, Norton ME, Rose NC, Schneider A, Stoll K, Wapner R, Watson MS. Expanded carrier screening in reproductive medicine-points to consider: a joint statement of the American College of Medical Genetics and Genomics, American College of Obstetricians and Gynecologists, National Society of Genetic Counselors, Perinatal Quality Foundation, and Society for Maternal-Fetal Medicine. Obstet Gynecol. 2015 Mar;125(3):653-662. doi: 10.1097/AOG.0000000000000666.