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Cytology Collection Methods for HPV Screening

N/A

Waitlist Available

Led By Dorothy Wiley

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolle

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares three anal cytology collection procedures and two HPV tests in men who have sex with men to help develop better screening for high-grade anal dysplasia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive specimen collection and laboratory analysis rather than drug interventions, significant side effects are not anticipated. However, participants may experience minor discomfort or bleeding from the sampling procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome

Secondary study objectives

Ability of APTIMA-HPV to predict risk for HG-AIN

Ability of Hybrid-capture 2 to predict risk for HG-AIN

Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.