Recruiting

Self-Collection Study

Sponsor:

University of British Columbia

Code:

NCT07194551

Conditions

Endometrial Cancer

Lynch Syndrome

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Vaginal DNA swab, microbiome swab and pH test

Study Details

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 ID

NCT07194551

Start date

Aug 29, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Feasibility and Acceptability of Self-collected Vaginal DNA to Assess for the Presence of Mutations Related to EC or EC Precursors [ Time Frame: Through study completion, anticipated 1-2 years ]

Central Contacts and Locations

Central contacts

Aline Talhouk, PhD

604-875-4111a.talhouk@ubc.ca

Research Assistant

604-875-4111

Locations

VGH Research Pavilion

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Aline Talhouk, PhD

604-875-4111a.talhouk@ubc.ca

Principal Investigator:

Aline Talhouk, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Reproductive Health
  • Lynch Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-09-03.