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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,367 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,929,956 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,506,871 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male who has sex with men, and I may or may not have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Screening (anal cytology collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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