Self-Sampling Methods for Anal Cancer

(SOLOPilot Trial)

Overseen By Jenna Nitkowski, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Severe anal disease, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for self-sampling cells from the anus to detect early signs of anal cancer. Researchers are comparing two swab insertion depths, 3 cm and 5 cm, to identify which depth collects better samples from a specific area inside the anus that can develop cancer. The study seeks participants who are either sexual minority men or women with a gender identity different from their birth sex, living in the Milwaukee area, and able to understand English. Participants will help identify which swab method is most effective and comfortable. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance early 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 these self-sampling methods are safe?

Research shows that using swabs at home for anal cancer screening is generally easy for people. Studies have found that swabs inserted either 3 cm or 5 cm into the anus can be as effective as those taken by a doctor. This allows people to perform these tests at home and usually find them manageable.

For the 5 cm swab, research suggests it is safe. Although deeper insertion might cause some discomfort, it helps collect a better sample. Importantly, no serious problems have been reported.

The 3 cm swab is also easy for most people to use. It doesn't go as deep, which might be more comfortable, yet still provides a good sample for testing.

Both self-sampling methods are considered safe for home use. They offer a convenient way to conduct regular screenings without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring self-sampling methods for anal cancer screening, which could make early detection more accessible. Unlike traditional screening methods that often require clinic visits and professional assistance, this approach empowers individuals to perform the test themselves at home. By comparing two different self-sampling depths, researchers aim to find out which method is more effective for detecting potential cancerous changes. This could lead to a more convenient and less invasive screening option, potentially increasing early detection rates and improving outcomes.

What evidence suggests that these self-sampling methods could be effective for anal cancer?

Research has shown that using a swab at home to collect a sample from the anus can effectively screen for anal cancer. One study found that over 89% of participants successfully returned their samples, demonstrating the method's practicality. In this trial, participants in the intervention arm will insert the swab 5 cm into the anus, while those in the control arm will insert it 3 cm. The swabs are designed to collect cells from a specific area more likely to develop cancer. The study also found that participants could follow instructions to insert the swab 3 to 5 cm, which is crucial for obtaining a good sample. Overall, self-swabbing at home shows promise in encouraging more people to participate in anal cancer screening. ^{2 4 5 6 7}

Who Is on the Research Team?

Alan Nyitray, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for English-speaking sexual minority men and transgender women over 35 years old living in the Milwaukee area. Participants must understand and sign a consent form.

Inclusion Criteria

I live in the Milwaukee metropolitan area.

I can speak and understand English.

I can understand and am willing to sign the informed consent document.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Consenting and Randomization

Eligible participants are consented and randomized to either the intervention or control arm

1 day

1 visit (in-person)

Cytology Sampling

Participants perform self-sampling using a swab at either 3 cm or 5 cm insertion depth

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cytology results and user acceptability

Several months

What Are the Treatments Tested in This Trial?

Interventions

• Inserting a swab 5 cm into the anus during self-sampling
• Self-sampling with a swab by inserting the swab 3 cm into the anus

Trial Overview The study tests how well two different depths of self-inserted anal swabs (3 cm vs. 5 cm) collect cells from an area prone to cancer development, aiming to determine the optimal depth for cell collection.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.

Group II: Control arm Active Control 1 Intervention

Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0312781

Self- versus clinician-collected swabs in anal cancer screening They were instructed to insert the swab 3–5cm into their anal canal, then firmly rotate and dab it against the walls of the anal canal for about ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37158105/

The Prevent Anal Cancer Self-Swab Study - PubMed - NIH A total of 89.2% and 74.2% of home-arm and clinic-arm individuals returned the swab, respectively (P = .003), difference between groups, 15.0% ( ...

3. asccp.org asccp.org/Assets/fe4f356f-615e-4535-be48-bbc3bd3df971/636602528892070000/0430-nicholas-yared-pdf

and Clinician-Collected Anorectal Swabs for Human ... • Polyester-tipped swab (Puritan Medical Products,. Guilford, Maine) inserted 3-4 cm into anal canal. • Swab rotated once for self-collection and then removed ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/11/6/e051118

a protocol for a randomised clinical trial of home-based self ... This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based sampling of anal canal exfoliated ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT03489707/Prot_SAP_002.pdf

the prevent anal cancer (pac) self-swab study Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: A randomised trial. Br J ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07085845

Study Details | NCT07085845 | The Self-Sampling Pilot Study The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells. What ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9645463/

Effect of the environment on home-based self-sampling kits ... These real-world data from mailed home-based anal self-sampling kits found that environmental conditions did not affect specimen adequacy.