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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

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 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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Screening (anal cytology collection)Experimental Treatment2 Interventions
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytology Specimen Collection Procedure
2017
N/A
~26870

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,014 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,585 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,096 Total Patients Enrolled

Media Library

Cytology Specimen Collection Procedure Clinical Trial Eligibility Overview. Trial Name: NCT02816879 — N/A
Anal Cancer Research Study Groups: Screening (anal cytology collection)
Anal Cancer Clinical Trial 2023: Cytology Specimen Collection Procedure Highlights & Side Effects. Trial Name: NCT02816879 — N/A
Cytology Specimen Collection Procedure 2023 Treatment Timeline for Medical Study. Trial Name: NCT02816879 — N/A
~23 spots leftby Jun 2025
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