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

NCT ID: NCT07194551

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2027-04-30

Brief 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

Endometrial Cancer; Lynch Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaginal DNA swab, microbiome swab and pH test

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Zymo DNA/RNA Shield Swab Kit; DNAGenotek Inc. OMNIgene (OMR-130) Vaginal Microbiome Swab Kit; Gynex pHem-Alert Vaginal pH test

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Aline Talhouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VGH Research Pavilion

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Aline Talhouk, PhD

Role: CONTACT

a.talhouk@ubc.ca

604-875-4111 ext. 21365

Research Assistant

Role: CONTACT

604-875-4111 ext. 21369

Facility Contacts

Aline Talhouk, PhD

Role: primary

a.talhouk@ubc.ca

604-875-4111 ext. 21365

Other Identifiers

H24-00911

Identifier Type: -

Identifier Source: org_study_id