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

Not Applicable

Active, not recruiting

• Conditions: Human Papillomavirus Infection; Anal Carcinoma; HIV Infection
• Interventions: Procedure: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02816879
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

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).

Study Timeline

• Study Start: 2013-08-01
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 415

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (anal cytology collection)	Cytology Specimen Collection Procedure	Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
Screening (anal cytology collection)	Laboratory Biomarker Analysis	Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.

Primary Outcome Measures

Name	Time	Method
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome	Baseline	Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology.

Secondary Outcome Measures

Name	Time	Method
Ability of Hybrid-capture 2 to predict risk for HG-AIN	Baseline	Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form.
Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.	Up to 3 years	The cost-effectiveness analyses calculate incremental cost-effectiveness ratios (ICERs) comparing two intervention groups/strategies to the current standard of care, Dacron cytology alone. The ICER is the ratio of the difference in the total costs per patient between groups (numerator) versus the difference in quality-adjusted life-years (QALY) between groups (denominator). Specifically, for these analyses, ICERs are separately estimated for best single \& best combination screening algorithm relative to usual care (Dacron-cytology). The analysis focuses on life-time costs.
Ability of APTIMA-HPV to predict risk for HG-AIN	Baseline	Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form.

Trial Locations

Locations (3)

Los Angeles Gay and Lesbian Center; 🇺🇸 Los Angeles, California, United States

Desert AIDS Project; 🇺🇸 Palm Springs, California, United States

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States