Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Healthy Volunteers: f
View:

• Diagnosed with Lynch syndrome (confirmed by genetic testing).

• Have an intact uterus.

• Age 30 years or older.

Locations
Other Locations
Canada
VGH Research Pavilion
RECRUITING
Vancouver
Contact Information
Primary
Aline Talhouk, PhD
a.talhouk@ubc.ca
604-875-4111
Backup
Research Assistant
604-875-4111
Time Frame
Start Date: 2025-08-29
Estimated Completion Date: 2027-04
Participants
Target number of participants: 30
Treatments
Experimental: Vaginal self-collection
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.~Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: Vancouver Coastal Health Research Institute
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov