Vaginal Self-sampling for Endometrial Cancer

(Lynch-SCAN Trial)

Overseen By Aline Talhouk, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Endometrial cancer, Pelvic radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether individuals with Lynch syndrome (a genetic condition that increases cancer risk) can use self-collected vaginal swabs to detect early signs of uterine cancer. Researchers aim to determine if these self-swabs can predict cancer risks as effectively as other tests. Participants will use at-home kits to swab and measure vaginal pH while answering questions about health and lifestyle. This trial is open to those diagnosed with Lynch syndrome, who still have their uterus, and have no history of endometrial problems. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to easier, at-home cancer detection methods.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this self-sampling method is safe for participants?

Research has shown that collecting one's own vaginal samples is generally safe and easy. In studies where participants used swabs to collect samples themselves, they found the process simple and acceptable. This method effectively detects signs of endometrial (uterine) cancer.

Studies have not reported major problems with self-sampling. Participants can use swabs at home, reducing hospital visits and making participation easier. This method is convenient for many and does not involve invasive procedures, enhancing its safety.

Overall, evidence suggests that vaginal self-sampling is a safe way to collect samples for checking early signs of cancer. Participants usually manage the process well and feel comfortable with it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vaginal self-sampling technique for endometrial cancer because it offers a non-invasive, convenient alternative to traditional methods like biopsies and clinical examinations. This approach allows individuals to collect samples in the comfort of their homes, potentially increasing participation rates and early detection. The use of advanced tools for DNA and microbiome sampling coupled with pH testing could provide a comprehensive overview of vaginal health, leading to earlier identification of abnormal changes. This method could revolutionize how we approach endometrial cancer screening by making it more accessible and less intimidating.

What evidence suggests that vaginal self-sampling is effective for detecting early signs of uterine cancer in people with Lynch syndrome?

Research has shown that using a vaginal swab for self-sampling could help detect early signs of endometrial cancer. In this trial, participants will use vaginal self-sampling kits to collect DNA. Studies have found that this method can reveal cancer risks by detecting information from tumor cells. It is simple and minimally invasive, making it a promising tool for early detection. Initial results suggest that self-sampling can reliably replace more invasive procedures. Additionally, individuals with Lynch syndrome, a genetic condition that increases cancer risk, might find this method helpful for early detection. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Lynch syndrome who still have their uterus. Participants will need to be comfortable with self-collecting vaginal swabs at home and answering health questionnaires about their lifestyle and symptoms.

Inclusion Criteria

I have an intact uterus.

I have been diagnosed with Lynch syndrome through genetic testing.

I am 30 years old or older.

Exclusion Criteria

Pregnant at the time of study enrolment or during the study

I have a history of endometrial cancer or endometrial hyperplasia.

I have had radiation therapy or endometrial ablation in the pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-collection

Participants collect their own vaginal swabs and measure vaginal pH at home using a self-collection kit

8-9 months per collection cycle, up to 3 cycles

At-home collection

Follow-up

Participants are monitored for safety and effectiveness after self-collection, with abnormal findings referred for clinical assessment

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Self-sampling

Trial Overview The study tests the effectiveness of using self-collected vaginal DNA swabs, microbiome swabs, and pH tests to detect early signs of uterine cancer in Lynch syndrome carriers. It also evaluates participant willingness and the acceptability of this self-collection method.

How Is the Trial Designed?

Group I: Vaginal self-collection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Vancouver Coastal Health Research Institute

Collaborator

Trials

30

Recruited

5,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960138/

Detection of endometrial cancer in cervico-vaginal fluid and ... These data suggest that cervico-vaginal fluid protein panels could offer simple, minimally invasive endometrial cancer detection tools and ...

2. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.e17617

Feasibility of vaginal tampon versus swab in the collection ... Download article citation data for: Feasibility of vaginal tampon versus swab in the collection of vaginal fluid for endometrial cancer testing.

3. withpower.com withpower.com/trial/phase-endometrial-neoplasms-7-2025-2bb80

Vaginal Self-sampling for Endometrial Cancer 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06672341

Clinical Studies of Endometrial Cytology and Cervical ... The pipelle aspiration method, known for its simplicity and reliability, shows a sample adequacy rate of 73.9% to 100%, with a sensitivity of 77.4% to 94.1% and ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/31/14/2978/763486/Genomic-Profiling-in-Patients-with-Endometrial

Genomic Profiling in Patients with Endometrial Cancer by ... Vaginal swab DNA may help overcome the low detection rate of plasma-based ctDNA by directly capturing the genomic profiles of heterogeneous tumor cells shed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07194551

Assessing Uterine Cancer Risk in Lynch Syndrome ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8320249/

DEveloping Tests for Endometrial Cancer deTection ... A sample size of 2000 women will have 80% power to establish a sensitivity of vaginal samples for endometrial cancer detection by cytology of ≥ ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e17617

Feasibility of vaginal tampon versus swab in the collection ... Sampling vaginal fluid with provider-collected swabs or self-collected tampons are both effective for detection of validated EC MDMs.

9. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/a-substantial-step-toward-earlier-endometrial-cancer-detection/mac-20560620

A substantial step toward earlier endometrial cancer ... A Mayo Clinic-led study has made significant strides toward timelier endometrial cancer (EC) detection, improving the likelihood of cure due to disease ...