Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
5 other identifiers
interventional
415
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
July 29, 2025
July 1, 2024
12.8 years
May 23, 2016
July 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology.
Baseline
Secondary Outcomes (3)
Ability of APTIMA-HPV to predict risk for HG-AIN
Baseline
Ability of Hybrid-capture 2 to predict risk for HG-AIN
Baseline
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
Up to 3 years
Study Arms (1)
Screening (anal cytology collection)
EXPERIMENTALPatients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Interventions
Undergo anal cytology collection
Eligibility Criteria
You may qualify if:
- 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 enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (3)
Los Angeles Gay and Lesbian Center
Los Angeles, California, 90028, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Desert AIDS Project
Palm Springs, California, 92262, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy Wiley
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
June 29, 2016
Study Start
August 1, 2013
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
July 29, 2025
Record last verified: 2024-07