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

NCT07194551 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-26

No results posted yet for this study

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

Conditions

Interventions

COMBINATION_PRODUCT

Vaginal DNA swab, microbiome swab and pH test

Participants will receive up to three at-home collection kits with a vaginal swab for DNA collection, a vaginal swab for microbiome sampling, a vaginal pH testing kit, and instructions on how to perform the sample collection. Vaginal DNA will be collected using Zymo DNA/RNA Shield, vaginal microbiome DNA will be collected using Genotek OMNIgene, and vaginal pH will be collected using GYNEX pHem-Alert. Those with abnormal findings will be referred to a gynecologist or gynecologic oncologist for appropriate clinical assessment. Those with negative pathology will remain in the study. The self-collection will be repeated up to two more times, at eight-to-nine-month intervals, up to three successful self-collections.

Sponsors & Collaborators

  • Vancouver Coastal Health Research Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2026-08-31
Completion
2027-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194551 on ClinicalTrials.gov