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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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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

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Anal Carcinoma HIV Infection Human Papillomavirus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (anal cytology collection)

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

Group Type EXPERIMENTAL

Cytology Specimen Collection Procedure

Intervention Type PROCEDURE

Undergo anal cytology collection

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Cytology Specimen Collection Procedure

Undergo anal cytology collection

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes