Actively Recruiting

Phase Not Applicable
Age: 30Years +
FEMALE
ID07194551

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

Age: 30Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Lynch syndrome confirmed by genetic testing
  • Have an intact uterus
  • Age 30 years or older
Not Eligible

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

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (remote or in-person)

Surveillance

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

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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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