Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire

Not Applicable

Recruiting

• Conditions: Endometrial Cancer; Lynch Syndrome

• Registration Number: NCT07194551
• Lead Sponsor: University of British Columbia

Brief Summary

The goal of this study is to find out if self-collected vaginal swabs can be used to detect early signs of uterine cancer or related conditions in people with Lynch syndrome (LS) who still have their uterus. The study also tests if people with LS are willing and able to collect these samples themselves and whether they find the process acceptable.

The main questions this study asks are:

* Will people with LS take part in self-collection of vaginal samples, and do they find it acceptable?

* Can vaginal DNA mutations predict cancer risk or match results from other genetic or biopsy testing?

* Can a cancer risk model used in the general population also help identify risk in people with LS?

Participants will:

* Answer a health questionnaire about lifestyle and symptoms

* Collect their own vaginal swabs and measure their vaginal pH at home using a self-collection kit

* Complete short surveys around the time of self-collection and at the end of the study

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2026-08
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Diagnosed with Lynch syndrome (confirmed by genetic testing).
• Have an intact uterus.
• Age 30 years or older.

Exclusion Criteria

• History of endometrial cancer or endometrial hyperplasia.
• History of pelvic radiation or endometrial ablation.
• Pregnant at the time of study enrolment or during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility and Acceptability of Self-collected Vaginal DNA to Assess for the Presence of Mutations Related to EC or EC Precursors	Through study completion, anticipated 1-2 years	Feasibility will be measured by enrollment and adherence rates. Enrollment is defined as interested individuals completing the first round of self-collection. Adherence is defined as compliance with returning vaginal DNA samples, completing the health questionnaire, and submitting the exit survey. Acceptability will be measured through responses to a questionnaire post-self-collection and an exit survey, evaluating ease and overall experience with the self-collection process.

Trial Locations

Locations (1)

VGH Research Pavilion; 🇨🇦 Vancouver, British Columbia, Canada