Actively Recruiting
Lynch Syndrome Carriers' Uterine Cancer Health Assessment Using Vaginal Self-sampling and DNA Detection
Led by University of British Columbia · Updated on 2025-09-26
30
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
V
Vancouver Coastal Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether self-collected vaginal swabs can detect early signs of uterine cancer or related conditions in people with Lynch syndrome who still have their uterus. The study also explores participants' willingness and ability to collect these samples themselves and how acceptable they find the process. Key questions include if vaginal DNA mutations can predict cancer risk and if existing cancer risk models apply to this group. Participants will receive up to three at-home collection kits. Each kit includes a vaginal swab for DNA collection, a swab for microbiome sampling, a vaginal pH testing kit, and detailed instructions. Self-collection is done at home, repeated up to three times at intervals of eight to nine months. Participants with abnormal test results will be referred to specialists for further clinical evaluation. During the study, participants will complete health questionnaires about lifestyle and symptoms and short surveys around the times of self-collection and at study completion. Researchers will measure how feasible and acceptable self-collected vaginal DNA testing is, monitoring for mutations linked to endometrial cancer or its precursors. The study is expected to last one to two years, with ongoing safety and clinical follow-up for those with abnormal findings.
CONDITIONS
Brief Title
Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Lynch syndrome confirmed by genetic testing
- Have an intact uterus
- Age 30 years or older
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (remote or in-person)
Duration - Up to 18 to 27 months
Participants perform up to three at-home vaginal self-collections for DNA, microbiome, and pH testing to assess uterine cancer risk. Collections are spaced at eight-to-nine-month intervals. Participants with abnormal results will be referred for clinical assessment, while those with negative results continue in the study.
Up to 3 at-home self-collection kits used over the study period
Trial Site Locations
Total: 1 location
1
VGH Research Pavilion
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
A
Aline Talhouk, PhD
R
Research Assistant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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