Cytology Collection Methods for HPV Screening

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

415 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

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 data supports the effectiveness of the treatment Cytology Specimen Collection Procedure for HPV screening?

Research shows that using liquid-based cytology, which is part of the Cytology Specimen Collection Procedure, improves the quality of samples and helps in better detection of HPV, which is important for cervical cancer screening. This method also allows for automated testing, which can be more efficient and cost-effective. ^{1 2 3 4 5}

Is the cytology collection method for HPV screening safe for humans?

The studies suggest that self-collected samples for HPV testing are generally safe and well-accepted by women, providing a promising alternative to traditional clinician-collected methods. ^{6 7 8 9 10}

How does the HPV self-collection method differ from other HPV screening treatments?

The HPV self-collection method allows individuals to collect their own samples for HPV testing, which is different from traditional methods where a healthcare provider collects cervical samples. This approach is preferred by many women, is cost-effective, and has comparable sensitivity to provider-collected samples, making it a unique and patient-friendly option for cervical cancer screening. ^{6 11 12 13 14}

Research Team

Dorothy Wiley

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Development of an automated extraction procedure for detection of human papillomavirus DNA in liquid based cytology samples. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Primary screening for cervical cancer precursors by the combined use of liquid-based cytology, computer-assisted cytology and HPV DNA testing. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cytology, liquid-based cytology and automation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus detection in self-collected vaginal specimens and matched clinician-collected cervical specimens. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Discussions about self-obtained samples for HPV testing as an alternative for cervical cancer prevention. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Acceptability and usability of self-collected sampling for HPV testing among African-American women living in the Mississippi Delta. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A second generation cervico-vaginal lavage device shows similar performance as its preceding version with respect to DNA yield and HPV DNA results. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cervical Cancer Screening-Past, Present, and Future. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of PCR- and hybrid capture-based human papillomavirus detection systems using multiple cervical specimen collection strategies. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]

13. England pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Randomized Comparison of Two Vaginal Self-Sampling Methods for Human Papillomavirus Detection: Dry Swab versus FTA Cartridge. [2018]