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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

25,660 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,738 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,173 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still recruiting participants?

"This medical research is no longer enrolling patients, as evidenced by the last update to its post on clinicaltrials.gov from September 27th 2022. Nonetheless, there exist 1101 other studies that still require participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

2013. "Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02816879.

All > Anal Cancer > Hpv