The purpose of this study is to examine the role of the bacterial environments and metabolites in the early detection and prediction of ovarian cancer development. Vaginal swabs and stool samples will be collected from healthy volunteers, or those without a known ovarian cancer diagnosis or genetic ovarian cancer risk. These samples will be compared to samples from participants with increased cancer risk and ovarian cancer diagnoses.

This study will examine the role of the microbiome and its metabolites in early detection and prediction of ovarian cancer development. It has been previously shown that the composition and function of the microbiome may play a role in the development and progression of several types of cancer. One proposed mechanism by which the microbiome may contribute to cancer development is through the production of certain metabolic byproducts. Such metabolites produced or modified by the microbiome have emerged as a prominent factor with potential local and systemic effects on the host, and were proposed to mediate the microbiome's contribution to cancer development. Microbial metabolites can promote cancer development by activating signaling pathways that promote cell growth and survival. In addition, the microbiota affects carcinogenesis through the release of carcinogenic molecules, such as genotoxins, and through the production of tumor-promoting metabolites. Furthermore, microbial metabolites have been studied as potential biomarkers for cancer, with some research suggesting that certain microbial metabolites may be able to distinguish between healthy individuals and those with cancer. The microbiome of the female reproductive tract is relatively understudied compared to the gut microbiome, but recent studies have shown that it is present and diverse in various parts of the reproductive tract such as the vagina, cervix, and fallopian tubes. however, a microbiome or metabolome signature predictive of ovarian cancer has not yet been established. Eligible individuals will be consented to provide a one-time, self-administered vaginal swab sample and stool sample. Clinical research assistants/coordinators, genetic counselors, and/or study physicians will consent patients and process and store the samples of consented participants. Participants will be provided a stool collection kit at the time of consent with instructions for providing the sample and sending it back to the laboratory.

Inclusion Criteria:

• has ovaries

Exclusion Criteria:

• genetic mutations which increase risk of ovarian cancer: BRCA1/2, BRIP1, PALB2, Lynch Syndrome (MLH1, MSH2/EPCAM, MSH6) and ATM
• no genetic testing results or unknown genetic status
• prior cancer diagnosis
• prior cancer treatment
• HRT use
• Antibiotic use (1 month prior to providing sample)

Eligible participants will be patients of the Cancer Risk Evaluation Program at the Abramson Cancer Center. Patients who meet the above criteria will be approached to participate as healthy volunteers.

Deidentified data of patients samples, survey answers, and complementary medical information will be shared with investigators at Stanford and Columbia. This information will be used to identify factors for analysis such as prescribed medications, treatment types and timeframes, among others.

Data will be shared with investigators three months after enrollment is complete. This should provide time for enrolled subjects to complete participation, ensure all data entry is complete, and that all data from records is obtained.