NCT02816879

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the sensitivity \& specificity, predictive positive value (PPV), \& predictive negative value (PNV) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), \& protein (quality measures) from nylon-flocked (NF)- \& Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) \& human papillomavirus (HPV)-infections, using randomized-controlled study design. II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with \& without cytology, to predict HG-AIN. III. Evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms. OUTLINE: Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).

Conditions

• Anal Carcinoma
• HIV Infection
• Human Papillomavirus Infection

Interventions

Type	Name	Description
PROCEDURE	Cytology Specimen Collection Procedure	Undergo anal cytology collection
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-08-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2016-06-29
• Last updated: 2025-07-29

Locations

3 sites across 1 country: United States