Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06962059

Conditions

Ovarian Cancer

Genetic Predisposition to Disease

Eligibility Criteria

Sex: Female

Age: 30 - 50

Healthy Volunteers: Accepted

Interventions

Self-Administered Sample Collection

Study Details

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.

Conditions

Ovarian Cancer

Genetic Predisposition to Disease

Study ID

NCT06962059

Start date

Apr 21, 2025

Status verified date

Feb, 2026

Completion date

May 25, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 50

Healthy Volunteers: Accepted

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

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Self-Administered Sample Collection

Participants will collect vaginal swabs and a stool sample.

Primary outcome measure

  • Microbiome Involvement [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Catherine Wolfe, BA

215-360-0422catherine.wolfe@pennmedicine.upenn.edu

Jamie Brower, MS

215-662-7245jabrower@pennmedicine.upenn.edu

Locations

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Susan Domchek, MD

855-216-0098PennCancerTrials@emergingmed.com

Principal Investigator:

Susan Domchek, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • vaginal metabolome
  • ovarian cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-02-05.