Cytology Collection Methods for HPV Screening

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to screen for anal cancer in men who have sex with men (MSM). It compares three cytology specimen collection procedures to determine the most effective for detecting high-grade anal dysplasia, a condition that can lead to cancer. The trial also evaluates two tests for the human papillomavirus (HPV), which is associated with this condition. Men who have had or currently have sex with men, regardless of HIV status, are encouraged to participate. As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance future screening methods.

Will I have to stop taking my current medications?

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

What prior data suggests that these cytology collection methods are safe for HPV screening?

Research shows that anal cytology, a test that collects cells from the anal area, is generally safe for screening. Past studies have demonstrated that this test effectively detects HPV, a virus linked to anal cell changes that can lead to cancer.

No direct evidence indicates serious side effects from the cell collection process itself. The methods used in this trial, such as swabbing to collect samples, resemble those in regular screenings. This similarity suggests that the procedure is well-tolerated, with few, if any, negative effects reported.

Overall, collecting anal cytology samples is considered safe and is a routine part of checking for HPV-related issues. The trial aims to compare different sample collection methods to find the most effective one, but safety should not be a major concern based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cytology Specimen Collection Procedure for HPV screening because it explores a new method of collecting anal cytology samples using two NF swabs and one Dacron swab. This approach is unique as it combines multiple swabs to enhance the accuracy and reliability of detecting HPV through Pap staining, HPV genotyping, and PCR. Unlike traditional methods that might rely on fewer or different swab types, this method could potentially provide a more comprehensive analysis, leading to earlier and more accurate detection of HPV-related changes.

What evidence suggests that these cytology collection methods are effective for HPV screening?

Research has shown that using both anal cytology (a test that examines cells from the anus) and high-risk HPV testing effectively detects serious anal cell changes. One study reported a success rate of 78.5% for identifying individuals with these changes, comparable to tests used for cervical cancer screening. This indicates that the test can reliably identify significant changes before they develop into anal cancer. The trial will evaluate the effectiveness of the anal cytology collection method using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR. This method could help identify individuals who need further screening or treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Dorothy Wiley

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men who have sex with men (MSM), regardless of their HIV status. It aims to find the best way to screen for high-grade anal dysplasia, a precursor to anal cancer, by comparing three different methods of collecting cells from the anus and two tests for HPV.

Inclusion Criteria

I am a male who has sex with men, and I may or may not have HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

1 visit (in-person)

Cytology Collection

Participants undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after cytology collection

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Cytology Specimen Collection Procedure

Trial Overview The study is testing three anal cytology collection procedures and two HPV tests in one visit. The goal is to determine which method and test are most effective at predicting high-grade anal dysplasia in MSM, potentially improving early screening practices.

How Is the Trial Designed?

Group I: Screening (anal cytology collection) Experimental Treatment 2 Interventions

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Self-collected vaginal samples for HPV testing showed lower sensitivity (72%) compared to physician-collected samples (92%), indicating that self-collection may not be as reliable for cervical cancer screening.

While self-collected PAP tests had a high positive predictive value, their sensitivity was only 52%, suggesting that self-collection might not improve screening efficiency in cervical cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-collection of test material. Supplement to cervical cancer screening]. Mangold, BR.[2022]

A study involving 18 healthcare providers in Oregon revealed that while there are concerns and barriers to implementing HPV self-collection for cervical cancer screening, there is a strong willingness among providers to offer this option once it becomes available.

Providers believe that HPV self-collection is accepted by patients and emphasize the need for its inclusion in national screening guidelines to enhance cervical cancer screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. Bohn, JA., Fitch, KC., Currier, JJ., et al.[2023]

Self-collection of cervical samples for hr-HPV detection showed a significant error rate, with 9.1% of samples at UZ Ghent and 17.6% at AML failing to provide an internal control signal, indicating potential issues with sample quality.

Despite the high error rates, the prevalence of hr-HPV in the valid samples was 18.8%, suggesting that self-collection could still be a viable method for screening, but adjustments in testing protocols may be needed to account for differences in sample collection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. Verberckmoes, B., De Vos, T., Maelegheer, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4868083/

Anal Cytology and Human Papillomavirus Genotyping in ... In the high-risk group, of the 77 women with abnormal anal cytology, 38 tested negative for anal HPV, 15 had insufficient HPV results, and one was not completed ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213294521000429

Evaluation of high-risk human papillomavirus testing and ... Combined HPV testing and cytology had the highest sensitivity for ≥AIN2 detection, with a performance comparable to cervical cancer screening tests.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncy.22738

Evaluating the performance of anal cytology and high‐risk ... When combining anal cytology and HR-HPV (where both screening tests are positive), the sensitivity decreased to 78.5% (95% CI, 72.0%–84.1%) when ...

4. clinicaltrial.be clinicaltrial.be/en/details/10073?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Anal Cytology Collection Procedures in Predicting High-Gr... Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and ...

5. mdpi.com mdpi.com/2075-4418/15/4/419

Retrospective Analysis of Human Papillomavirus ... For tests with cytology alone, 178 out of 4353 tests (4.1%) yielded abnormal cytology results. When the HPV test was performed alone, 283 out of 2711 tests ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524277/

Anal Cancer and Anal Cancer Screening - PMC Like cytology, high-risk HPV testing had higher sensitivity (96%), but lower specificity (30%) among studies restricted to MSM LWH. Compared to ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230003B.pdf

Summary of Safety and Effectiveness Data (SSED) All specimens collected were tested for HPV infection by Alinity m HR HPV and an FDA approved HPV test performed according to manufacturer's instructions.

8. academic.oup.com academic.oup.com/cid/article/74/Supplement_2/S179/6567970

Anal Cancer Screening and Prevention: Summary of Evidence ... This article summarizes key questions, evidence, recommendations, and areas for further research for the screening, diagnosis, and prevention of anal cancer.

9. hivguidelines.org hivguidelines.org/guideline/hiv-anal-cancer/

Screening for Anal Dysplasia and Cancer in Adults With HIV In a study evaluating the anal cytology samples of 62 transgender women, 69% of whom had HIV, 47% had anal dysplasia and 74% had high-risk HPV ...

10. mdpi.com mdpi.com/2077-0383/13/17/5246

Screening of Anal HPV Precancerous Lesions: A Review ... Cytology and HR-HPV co-testing is acceptable for anal cancer screening (BII). They recommend immediate HRA for individuals with ASC-US+ cytology and HPV ...