Self-sampling for Anal Cancer

(SOLO Trial)

Recruiting at 2 trial locations

Overseen By Jenna Nitkowski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Anticoagulants

Disqualifiers: Hemophilia, Cirrhosis, Thrombocytopenia, others

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

Compensation: Varies

Number of Visits: Unknown

572 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to encourage anal cancer screening for those at higher risk. It explores whether people are more likely to attend follow-up appointments when they self-sample at home or when a clinician collects the sample at the clinic. Participants will either self-sample or have a clinician collect a sample. This trial suits cisgender or transgender sexual minority men and transgender women who have sex with men, live in Chicago, Houston, or Milwaukee, and can attend a study clinic and understand English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to research that could improve screening methods for at-risk communities.

Will I have to stop taking my current medications?

If you are currently taking anticoagulants (blood thinners) other than aspirin or NSAIDs like ibuprofen or naproxen, you would not be eligible to participate in the trial. The protocol does not specify other medication restrictions.

What prior data suggests that self-sampling for anal cancer is safe?

Studies have shown that self-sampling for anal cancer is generally safe and well-tolerated. Research indicates that self-collected swabs are about as effective as those taken by a doctor for testing certain conditions, like HPV, though they might be slightly less effective for other tests. This method is considered acceptable and practical for use in clinics.

Regarding the types of swabs used, the nylon-flocked swab is known for collecting cells effectively. Some studies suggest it might gather more cells than the Dacron swab. However, comfort can vary, with some people finding nylon-flocked swabs less comfortable.

Overall, self-sampling is a promising and safe option for anal cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method for detecting anal cancer, focusing on self-sampling. Unlike traditional clinician-administered tests, this approach allows individuals to collect samples at home, potentially increasing convenience and accessibility for patients. The trial also investigates the effectiveness of different swab materials—nylon-flocked and Dacron—to determine which offers the best results. This could lead to more personalized and less invasive testing options, making early detection of anal cancer more accessible and improving patient experience.

What evidence suggests that self-sampling is effective for increasing anal cancer screening?

This trial will compare self-sampling with clinician sampling for anal cancer screening. Research has shown that people can collect their own swabs for anal cancer screening, offering a practical and low-cost alternative to clinician collection. While self-sampling might sometimes be less effective for certain tests, it remains a viable option for screening. Nylon-flocked swabs, one of the types used in this trial, effectively capture cells and germs, potentially improving test results compared to Dacron swabs, another type under study. This improvement can aid in better detecting serious lesions, crucial for early cancer detection. Overall, these findings suggest that using nylon-flocked swabs for self-sampling could effectively screen for anal cancer. ^{2 3 6 7 8}

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 individuals at increased risk for anal cancer. Participants will be asked to perform self-sampling of the anal canal to see if it encourages them to attend more screening appointments. The study also looks at whether giving people a choice between self-sampling and healthcare provider sampling affects clinic attendance.

Inclusion Criteria

Ability to understand a written informed consent document, and the willingness to sign it

Resides in Chicago, Houston, or Milwaukee metropolitan area

Is willing to attend a study clinic

Exclusion Criteria

Was a participant in the PAC Self-Swab Study in Milwaukee

Plans to move within 12 months after enrollment

I am taking blood thinners, but not aspirin or NSAIDs like ibuprofen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants perform self-sampling of the anal canal or have clinician sampling, using either nylon-flocked or Dacron swabs

1-2 months

Home and clinic visits

Follow-up

Participants are monitored for appointment attendance and sample adequacy

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Self-sampling

Trial Overview The intervention being tested is self-sampling using a nylon-flocked swab, compared with standard healthcare provider sampling. The goal is to determine if this method increases patient participation in cytology tests and high-resolution anoscopy (HRA) screenings.

How Is the Trial Designed?

Group I: Self-sampling Experimental Treatment 1 Intervention

Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.

Group II: Nylon-flocked swab Experimental Treatment 1 Intervention

This is a swab with nylon-flocked material at the tip.

Group III: Clinician sampling Active Control 2 Interventions

A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.

Group IV: Dacron swab Active Control 2 Interventions

This is a swab with a Dacron tip.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Froedtert Hospital

Collaborator

Trials

10

Recruited

10,700+

The University of Texas MD Anderson Cancer Center

Collaborator

Trials

2

Recruited

1,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7108036/

Comparison of Nylon-flocked swab and Dacron ... Nylon-flocked swabs are shown to trap pathogens and cells well. Thus, we compared test characteristics of anal cytology using nylon-flocked (NF) ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncy.22114

Comparison of nylon‐flocked swab and Dacron swab cytology ... Nylon-flocked (NF) swabs have been shown to trap pathogens and cells well. Thus, this study compared test characteristics of anal cytology using ...

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

Self- versus clinician-collected swabs in anal cancer screening However, evidence suggest that flocked swabs may perform slightly better than Dacron swabs for anal cytology [29, 30].

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00955591

Comparing Two Types of Swabs in Collecting Cell ... Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab, a day. Collaborators and Investigators.

5. mantacc.com mantacc.com/improved-detection-anal.html?srsltid=AfmBOoo-IEwBwHimJC9op4yo1NCbHXMJvGA0k7EJFCh0SApUxeVVW9Ko

Improved Detection of Anal hHSIL with Nylon-Flocked Swab The fully-adjusted analyses showed that only the NF-cytology improved overall accuracy for predicting hHSIL when compared to other factors such as swab order, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07192055

Self-sampling to Optimize Anal Lesion Outcomes (SOLO) Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the nylon-flocked swab.

7. mantacc.com mantacc.com/improved-detection-anal.html?srsltid=AfmBOoo_160DUxYJBjbctavvltE2BuZtQmaqWx-YQvoDocSc7kjO_qT6

Improved Detection of Anal hHSIL with Nylon-Flocked Swab Discover how a clinical trial comparing nylon-flocked and Dacron swabs for anal cytology revealed higher specificity and accuracy in predicting anal ...

8. copanusa.com copanusa.com/wp-content/uploads/2019/04/851426710050_Dacron-vs-FlockedSwabs-july11.pdf

A Comparison of Dacron versus Flocked Nylon Swabs for ... The data sug- gest that flocked nylon swabs might have yielded more anal cells than Dacron swabs. Greater cellular yields may increase the ...