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

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Anal Carcinoma; HIV Infection; Human Papillomavirus Infection

Treatments: Procedure: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02816879

RCA169508A (Other Identifier)

JCCCID370 (Other Identifier)

R01CA169508 (U.S. NIH Grant/Contract)

NCI-2014-01292 (Registry Identifier)

13-000997 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 415 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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415 participants in 1 patient group

Screening (anal cytology collection)

Experimental group

Description:

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Cytology Specimen Collection Procedure