Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test

Laser Surgery Care300 enrolled

Overview

This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

300

Conditions

Anal Canal HPV Infection Diagnosis Anal Dysplasia Diagnosis Anal Cancer

Interventions

HC2 collection kit with a swab or brushDEVICE

We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. male or female 18 years of age or older 2. screened for anal dysplasia, including MSM and women - Exclusion Criteria: 1. subject has had a previous treatment for anal cancer. 2. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection. 3. subjects that have bleeding disorders or use anticoagulation treatments. -

Locations (1)

Laser Surgery Care, Inc.

New York, New York, United States

Outcomes

Primary Outcomes

HC2 can accurately test for oncogenic HPV in anal specimens

Determination that HC2 testing in the anal canal can be performed

Time frame: in approximately 12 months

Secondary Outcomes

Sensitivity and specificity of cytology with HC2

To determine if HC2 improves the sensitivity and specificity of anal cytology

Time frame: in approximately 12 months

Data from ClinicalTrials.gov

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