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Healthy Volunteers Study

NCT06962059 · Abramson Cancer Center at Penn Medicine
In plain English

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Official title
Vaginal Metabolome Healthy Volunteers Study
About this study
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.
Eligibility criteria
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)
Study design
Enrollment target: 50 participants
Age groups: adult
Timeline
Starts: 2025-04-21
Estimated completion: 2027-05-25
Last updated: 2026-02-05
Interventions
Other: Self-Administered Sample Collection
Primary outcomes
  • Microbiome Involvement (One-time sample donation of vaginal swabs collected at the time of the patient's appointment. A subsequent stool sample will be provided within a week of the vaginal swab.)
  • Predictive Model (One-time sample donation of vaginal swabs collected at the time of the patient's appointment. A subsequent stool sample will be provided within a week of the vaginal swab.)
Sponsor
Abramson Cancer Center at Penn Medicine · other
Contacts & investigators
ContactCatherine Wolfe, BA · contact · catherine.wolfe@pennmedicine.upenn.edu · 215-360-0422
ContactJamie Brower, MS · contact · jabrower@pennmedicine.upenn.edu · 215-662-7245
InvestigatorSusan Domchek, MD · principal_investigator, University of Pennsylvania
All locations (1)
Abramson Cancer Center of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Healthy Volunteers Study · TrialPath