Healthy Volunteers Study

NCT ID: NCT06962059

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2026-05-25

Brief Summary

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.

Detailed Description

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.

Conditions

Ovarian Cancer; Genetic Predisposition to Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Volunteer

Females 30 or older who do not have a genetic predisposition to ovarian cancer, are unaffected by cancer, and have not had bilateral oophorectomy.

Self-Administered Sample Collection

Intervention Type: OTHER

Participants will collect vaginal swabs and a stool sample.

Interventions

Self-Administered Sample Collection

Participants will collect vaginal swabs and a stool sample.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Domchek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine Wolfe, BA

Role: CONTACT

catherine.wolfe@pennmedicine.upenn.edu

215-360-0422

Jamie Brower, MS

Role: CONTACT

jabrower@pennmedicine.upenn.edu

215-662-7245

Facility Contacts

Susan Domchek, MD

Role: primary

PennCancerTrials@emergingmed.com

855-216-0098

References

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Other Identifiers

UPCC 01025

Identifier Type: -

Identifier Source: org_study_id