Vaginal self-swabs and a health questionnaire to check uterine cancer risk in people with Lynch syndrome
Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection
This study tests whether people with Lynch syndrome who still have their uterus can use at-home vaginal swabs and a short health questionnaire to help spot early signs of uterine cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07194551 on ClinicalTrials.gov |
What this trial studies
The study enrolls people aged 30 or older with genetically confirmed Lynch syndrome who retain their uterus and are not pregnant, excluding those with prior endometrial cancer, endometrial hyperplasia, pelvic radiation, or endometrial ablation. Participants complete a health and symptom questionnaire, perform at-home self-collection of vaginal DNA and microbiome swabs, measure vaginal pH, and complete brief surveys at collection and study end. Investigators will measure how acceptable and feasible self-collection is and analyze vaginal DNA mutations and microbiome data to see whether they align with existing genetic or pathology findings and predict cancer risk. The project also explores whether a cancer risk model used in the general population can help identify higher-risk individuals among Lynch carriers.
Who should consider this trial
Good fit: Ideal candidates are people aged 30 or older with genetically confirmed Lynch syndrome who still have a uterus and can perform at-home sample collection and attend required visits.
Not a fit: People with prior endometrial cancer or endometrial hyperplasia, those who have had pelvic radiation or endometrial ablation, pregnant individuals, or those unable to self-collect samples are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable earlier, less invasive detection of uterine cancer risk and support more personalized surveillance for people with Lynch syndrome.
How similar studies have performed: Self-collected vaginal sampling has shown promise for detecting gynecologic disease in other populations, but its use specifically in Lynch syndrome carriers is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vancouver, British Columbia
- VGH Research Pavilion — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Aline Talhouk, PhD
- Email: a.talhouk@ubc.ca
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.