Genetic Risk Analysis in Ovarian Cancer (GRACE) Administrative Supplement

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PROJECT SUMMARY/ABSTRACT An estimated 1 in 190 women carry a pathogenic variant in BRCA1/2, which is associated with an 46-57% risk of breast cancer and 20-40% risk of ovarian cancer by age 70. Carriers account for 10% and 15% of breast and ovarian cancer cases, respectively, and up to 20% of high-grade serous ovarian cancer cases, the most aggressive subtype. Despite recommendations that all ovarian cancer cases should receive genetic counseling and testing, irrespective of family history and age at onset, a recent national study indicated that only 10% of cases underwent genetic testing. This represents a missed opportunity to inform these women and their at-risk family members about their future cancer risk. The parent study of the proposed supplemental project aims to address this care gap by applying a traceback testing approach to retrospectively identify women who have a prior diagnosis of ovarian cancer. Individuals with a prior diagnosis of ovarian cancer who have not received genetic testing will be offered genetic counseling, testing, and cancer risk assessment. This study will leverage tumor registries to identify prior cases of ovarian cancer diagnosed within the past 24 years at two managed care healthcare systems (Kaiser Permanente Northwest and Kaiser Permanente Colorado). The use of archived pathology samples for germline genetic testing will allow family members of both living and deceased women to receive familial genetic cancer risk information. We will assess: 1) the feasibility of and barriers associated with using tumor registries and archived pathology samples for a traceback testing approach, and 2) explore the ethical, privacy, and policy implications associated with genetic testing in deceased patients to inform familial risk. This parent study will generate evidence on the feasibility of traceback testing using tumor registries and archived pathology samples which is critically important to guide future implementation of such programs beyond ovarian cancer. This supplemental project will build upon the aims of the parent study by using a bioethical research approach to characterize the impact of social determinants on receipt of genetic risk information at the index ovarian cancer diagnosis. The supplement will leverage the infrastructure of the parent study and will use the study population identified at Kaiser Permanente Northwest and Kaiser Permanente Colorado as well as an additional site, Kaiser Permanente Washington. A mixed methods approach will combine electronic medical record analysis through chart review and abstraction with qualitative analysis to capture care pathways to characterize the role of social determinants of health at specific points in these care pathways, such as referral and uptake. The results of this supplement will expand upon the findings of the parent study to inform future traceback studies by ensuring equitable access to genetic risk information for all patients with ovarian and other hereditary cancers.