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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104181
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : June 22, 2011
QIAGEN Gaithersburg, Inc
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anal Canal HPV Infection Diagnosis Anal Dysplasia Diagnosis Anal Cancer Device: HC2 collection kit with a swab or brush Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: swab and brush or swab and swab
we will determine which collection method is superior
Device: HC2 collection kit with a swab or brush
We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
Other Name: Qiagen HC2 HPV High-Risk DNA Test

Primary Outcome Measures :
  1. HC2 can accurately test for oncogenic HPV in anal specimens [ Time Frame: in approximately 12 months ]
    Determination that HC2 testing in the anal canal can be performed

Secondary Outcome Measures :
  1. Sensitivity and specificity of cytology with HC2 [ Time Frame: in approximately 12 months ]
    To determine if HC2 improves the sensitivity and specificity of anal cytology

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104181

United States, New York
Laser Surgery Care, Inc.
New York, New York, United States, 10011
Sponsors and Collaborators
Laser Surgery Care
QIAGEN Gaithersburg, Inc
Principal Investigator: Stephen E Goldstone, MD Mount Sinai Medical School

Responsible Party: Stephen E. Goldstone, M.D., Laser Surgery Care Identifier: NCT01104181     History of Changes
Other Study ID Numbers: R09-HPV-001
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Laser Surgery Care:
Anal HPV
Anal Dysplasia
Ana Cancer

Additional relevant MeSH terms:
Anus Neoplasms
Papillomavirus Infections
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections