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

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Brief Title

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

Official Title

Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)

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.
    



Study Type

Interventional


Primary Outcome

HC2 can accurately test for oncogenic HPV in anal specimens

Secondary Outcome

 Sensitivity and specificity of cytology with HC2

Condition

Anal Canal HPV Infection Diagnosis

Intervention

HC2 collection kit with a swab or brush

Study Arms / Comparison Groups

 swab and brush or swab and swab
Description:  we will determine which collection method is superior

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

300

Start Date

March 2010

Completion Date

March 2011

Primary Completion Date

December 2010

Eligibility Criteria

        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. -
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Stephen E Goldstone, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01104181

Organization ID

R09-HPV-001



Study Sponsor

Laser Surgery Care

Collaborators

 QIAGEN Gaithersburg, Inc

Study Sponsor

Stephen E Goldstone, MD, Principal Investigator, Mount Sinai Medical School


Verification Date

June 2011