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

June 21, 2011 updated by: Laser Surgery Care

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10011
        • Laser Surgery Care, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Qiagen HC2 HPV High-Risk DNA Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laser Surgery Care

Collaborators

QIAGEN Gaithersburg, Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (ESTIMATE)

April 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09-HPV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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