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

Not Applicable

Completed

• Conditions: Anal Canal HPV Infection Diagnosis; Anal Dysplasia Diagnosis; Anal Cancer
• Interventions: Device: HC2 collection kit with a swab or brush

• Registration Number: NCT01104181
• Lead Sponsor: Laser Surgery Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
swab and brush or swab and swab	HC2 collection kit with a swab or brush	we will determine which collection method is superior

Primary Outcome Measures

Name	Time	Method
HC2 can accurately test for oncogenic HPV in anal specimens	in approximately 12 months	Determination that HC2 testing in the anal canal can be performed

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of cytology with HC2	in approximately 12 months	To determine if HC2 improves the sensitivity and specificity of anal cytology

Trial Locations

Locations (1)

Laser Surgery Care, Inc.; 🇺🇸 New York, New York, United States