Examining the role of vaginal microbiome in ovarian cancer detection
Official title: Vaginal Metabolome Healthy Volunteers Study
Run by Abramson Cancer Center at Penn Medicine · NCT06962059 · Data updated 2026-11-12
This study is trying to see if the bacteria in the vagina can help detect ovarian cancer earlier by comparing samples from healthy women and those at higher risk or already diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 50 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | April 21, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | May 25, 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT06962059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy women with ovaries who do not have a known diagnosis of ovarian cancer or genetic predisposition to it.
✕Probably not a fit
Patients with known genetic mutations that increase the risk of ovarian cancer or those with a prior cancer diagnosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate how bacterial environments and their metabolites may contribute to the early detection and prediction of ovarian cancer. Healthy volunteers will provide vaginal swabs and stool samples, which will be compared to samples from individuals at increased risk for ovarian cancer or those already diagnosed. The research focuses on understanding the microbiome's role in cancer development through its metabolic byproducts, which may serve as potential biomarkers for distinguishing healthy individuals from those with cancer.
Why it matters
Potential benefit: If successful, this study could lead to new methods for early detection of ovarian cancer, improving patient outcomes.
How similar studies have gone: While the role of the microbiome in cancer has been explored, this specific approach focusing on the vaginal microbiome in relation to ovarian cancer is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Susan Domchek, MD — University of Pennsylvania
- Study coordinator: Catherine Wolfe, BA
- Email: catherine.wolfe@pennmedicine.upenn.edu
- Phone: 215-360-0422
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.