ClinicalTrials.gg
RecruitingNCT07194551Lynch-SCANUpdated Sep 3, 2026

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

An interventional study of Vaginal DNA swab, microbiome swab and pH test in Endometrial Cancer and Lynch Syndrome, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by University of British Columbia · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
30 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 127 studies in Endometrial Neoplasms with a site in Canada — 36 open to participants now, 58 under way, 17 of them phase 3. Endometrial Neoplasms · Canada.

Planned enrollment
97th of 109
30 · median 156
Started
2025
with 11 others
No phase
17 of 127
6 open now
Primary completion
2027-04
later than 25 of 57 live
Registered
120th of 127
by date
Lead sponsor
4 of 127
University of British Columbia

Among the 127 studies in Endometrial Neoplasms with a site in Canada, this one is the 97th largest by planned enrollment of the 109 interventional ones that give a count, is one of 12 that started in 2025, is one of 17 with no phase, reaches primary completion later than 25 of the 57 other live ones, and was the 120th registered.

Endometrial Neoplasms

1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.

Browse Endometrial Neoplasms studies →

Open to participants now

36 of the 127 studies in Endometrial Neoplasms with a site in Canada are open now. Recruiting first, the newest first:

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All 36 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.

This study: 30 Years and older · female · no healthy volunteers.

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02

Study 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
03

Conditions studied

  • Endometrial Cancer
  • Lynch Syndrome

Keywords

  • Reproductive Health
  • Lynch Syndrome
04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with Lynch syndrome (confirmed by genetic testing).
  • Have an intact uterus.
  • Age 30 years or older.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study 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.

    Combination Product: Vaginal DNA swab, microbiome swab and pH test

Interventions

  • Combination productVaginal 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.

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

06

What researchers measure

Primary outcomes

  1. Feasibility and Acceptability of Self-collected Vaginal DNA to Assess for the Presence of Mutations Related to EC or EC Precursors

    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.

    Time frame: Through study completion, anticipated 1-2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 20 months after the start.

Of 195 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 20 months is below that.

Counting every sponsor, half of 201 studies reached it within 43 months; a quarter within 19 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2025
First posted
Sep 26, 2025
StartActual
Aug 29, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07194551
Collaborators
Vancouver Coastal Health Research Institute
Responsible party
Aline Talhouk (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Sep 26, 2025
Start date
Aug 29, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Aline Talhouk, PhD
Contact
a.talhouk@ubc.ca
604-875-4111 ext. 21365
Research Assistant
Contact
604-875-4111 ext. 21369

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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