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

This study has been completed.
Sponsor:
Collaborator:
QIAGEN Gaithersburg, Inc
Information provided by:
Laser Surgery Care
ClinicalTrials.gov Identifier:
NCT01104181
First received: March 25, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention
Anal Canal HPV Infection Diagnosis
Anal Dysplasia Diagnosis
Anal Cancer
Device: HC2 collection kit with a swab or brush

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)

Resource links provided by NLM:


Further study details as provided by Laser Surgery Care:

Primary Outcome Measures:
  • HC2 can accurately test for oncogenic HPV in anal specimens [ Time Frame: in approximately 12 months ] [ Designated as safety issue: No ]
    Determination that HC2 testing in the anal canal can be performed


Secondary Outcome Measures:
  • Sensitivity and specificity of cytology with HC2 [ Time Frame: in approximately 12 months ] [ Designated as safety issue: No ]
    To determine if HC2 improves the sensitivity and specificity of anal cytology


Enrollment: 300
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104181

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

No publications provided

Responsible Party: Stephen E. Goldstone, M.D., Laser Surgery Care
ClinicalTrials.gov Identifier: NCT01104181     History of Changes
Other Study ID Numbers: R09-HPV-001
Study First Received: March 25, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014