Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal DNA swab, microbiome swab and pH test.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer, Lynch Syndrome. Basic parameters: from 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection
Overview
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
Interventions
- Combination product 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 a
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 1 center
- VGH Research Pavilion — Vancouver
Identifiers
NCT: NCT07194551 · H24-00911