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NCT Number: NCT07194551

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Endometrial Cancer Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Lynch Syndrome Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VGH Research Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location status: Recruiting

Location contact

Aline Talhouk, PhD

CONTACT

[email protected]

604-875-4111 ext. 21365

Aline Talhouk, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal DNA swab, microbiome swab and pH test

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.

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

Primary outcomes

  1. 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

    Feasibility will be measured by enrollment and adherence rates. Enrollment is defined as interested individuals completing the first round of self-collection. Adherence is defined as compliance with returning vaginal DNA samples, completing the health questionnaire, and submitting the exit survey. Acceptability will be measured through responses to a questionnaire post-self-collection and an exit survey, evaluating ease and overall experience with the self-collection process.

Study contacts

Contact information is provided by the study sponsor or research team.

Aline Talhouk, PhD

CONTACT

[email protected]

604-875-4111 ext. 21365

Research Assistant

CONTACT

604-875-4111 ext. 21369

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Official study title

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

Acronym: Lynch-SCAN

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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