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

Laser Surgery Care

Status: Completed

Conditions: Anal Dysplasia Diagnosis; Anal Cancer; Anal Canal HPV Infection Diagnosis

Treatments: Device: HC2 collection kit with a swab or brush

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01104181

R09-HPV-001

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 1 patient group

swab and brush or swab and swab

Experimental group

Description:

we will determine which collection method is superior

Treatment:

Device: HC2 collection kit with a swab or brush