Endometrial CancerLynch-SCANNCT07194551
Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire
A study testing Vaginal DNA swab, microbiome swab and pH test in people with Endometrial Cancer and Lynch Syndrome, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Lynch Syndrome
- What is being tested?
- Vaginal DNA swab, microbiome swab and pH test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 29 Aug 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Lynch syndrome (confirmed by genetic testing).
- Have an intact uterus.
- Age 30 years or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Assistant contact
Canada1 site, 1 recruiting
- Recruiting
VGH Research Pavilion
Vancouver, British Columbia, V5Z 1M9
Aline Talhouk, PhD, 604-875-4111 ext. 21365, a.talhouk@ubc.ca
Aline Talhouk, PhD
About this study
Official title: Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection
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:
Read more
- 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
- Being tested
- Vaginal DNA swab, microbiome swab and pH test
- Keywords
- Reproductive Health, Lynch Syndrome
- Medical subject headings
- Endometrial Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal DNA swab, microbiome swab and pH testCombination product
Also called Zymo DNA/RNA Shield Swab Kit, DNAGenotek Inc. OMNIgene (OMR-130) Vaginal Microbiome Swab Kit, Gynex pHem-Alert Vaginal 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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal self-collection | Experimental | 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. Receives: Combination Product: Vaginal DNA swab, microbiome swab and pH test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, anticipated 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start29 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Aline Talhouk, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194551
- Sponsor's protocol ID
- H24-00911
- Acronym
- Lynch-SCAN
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection
- ClinicalTrials.gov ID
- NCT07194551
- Acronym / sponsor ID
- Lynch-SCAN / H24-00911
- Conditions
- Endometrial Cancer, Lynch Syndrome
- Keywords
- Reproductive Health, Lynch Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal self-collection | Experimental | Combination Product: Vaginal DNA swab, microbiome swab and pH testParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Lynch syndrome (confirmed by genetic testing).
- Have an intact uterus.
- Age 30 years or older.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal DNA swab, microbiome swab and pH testAlso: Zymo DNA/RNA Shield Swab Kit, DNAGenotek Inc. OMNIgene (OMR-130) Vaginal Microbiome Swab Kit, Gynex pHem-Alert Vaginal pH testParticipants 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. | Combination product | Vaginal self-collection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Assistant contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal DNA swab, microbiome swab and pH test in people with Endometrial Cancer and Lynch Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline Talhouk, PhD (604-875-4111 ext. 21365, a.talhouk@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.