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


N/A
18 Years
90 Years
Not Enrolling
Both
Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer

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Trial Information

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


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. -

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

HC2 can accurately test for oncogenic HPV in anal specimens

Outcome Description:

Determination that HC2 testing in the anal canal can be performed

Outcome Time Frame:

in approximately 12 months

Safety Issue:

No

Principal Investigator

Stephen E Goldstone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Medical School

Authority:

United States: Institutional Review Board

Study ID:

R09-HPV-001

NCT ID:

NCT01104181

Start Date:

March 2010

Completion Date:

March 2011

Related Keywords:

  • Anal Canal HPV Infection Diagnosis
  • Anal Dysplasia Diagnosis
  • Anal Cancer
  • Anal HPV
  • Anal Dysplasia
  • Ana Cancer
  • Anus Neoplasms

Name

Location
Laser Surgery Care, Inc. New York, New York  10011