Screening for HIV-Associated Anal Cancer

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Brief Title

Screening for HIV-Associated Anal Cancer

Official Title

Screening for HIV-Associated Anal Cancer

Brief Summary

      Cancer of the anus occurs at very high rates in young men with HIV and is caused by a virus
      called human papillomavirus (HPV). Anal cancer has increased during the HIV epidemic despite
      effective therapies for HIV. Unfortunately, anal cancer presents at a late stage because
      there is no screening program to find it at an early stage.

      Rates of other cancers such as cervical cancer have been reduced through the use of Pap
      smears. The researchers' plan is to do the same type of screening for anal cancer as has been
      done for cervical cancer. If abnormalities are found then treatment can be started. The
      researchers hope that this approach will help to prevent anal cancer.

      Testing for HPV will also be done to see if this helps to detect early cancer and to see how
      accurate different tests, pathologists and clinical examiners are at detecting and agreeing
      on any abnormalities.

      The main outcome is the presence of any pre-cancerous or early cancer changes as determined
      by high resolution anoscopy (HRA). HRA involves looking through a microscope into the anus
      and this allows very tiny changes to be identified. Pieces of tissue can then be taken to
      make a definite diagnosis.
    

Detailed Description

      Anal cancer occurs at a rate which is 163-fold greater in young men with HIV. It is caused by
      another virus, HPV. The incidence has doubled during the HIV epidemic and is not decreasing
      despite effective antiretroviral therapy. It is important to have an anal cancer screening
      program to detect precancerous lesions; this has been done for the prevention of cervical
      cancer through the use of cervical Pap smears.We will do anal Pap smears, HPV testing and
      perform high resolution anoscopy for a magnified and detailed view of the anus. Biopsies are
      done and early treatment is initiated. It is anticipated that this approach will help to
      prevent anal cancer.

      SPECIFIC AIMS:

      The aim of this study is to determine the accuracy of pathology and human papillomavirus
      (HPV) testing in identifying precancerous changes in HIV positive men. The primary question
      is to determine how good the anal Pap smears are for detecting precancerous changes in the
      anus. Secondary questions involve: (a) determination of the test characteristics of the anal
      Pap smear, (b) assessment of agreement in visually detecting pre-cancers by the anoscopists
      and, (c) a determination of the viral and patient characteristics that predict pre-cancer.

      STUDY DESIGN:

      This is a cross-sectional survey of HIV positive men with a history of anal receptive
      intercourse who are attending several Toronto HIV clinics. Relevant information is collected
      as well as anal specimens for assessment. There is a multidisciplinary team who have the
      appropriate expertise in these studies.

      OUTCOME MEASURES and STATISTICAL ANALYSIS:

      The primary outcome measure is the presence of pre-cancerous changes as determined by high
      resolution anoscopy. We need to screen 425 subjects in order to find 100 patients with high
      grade pre-cancerous changes.

      Secondary outcome analyses include specificity, positive predictive value and negative
      predictive value of cytology and HPV DNA testing to detect histologically confirmed
      pre-cancerous changes or cancer.
    


Study Type

Observational




Condition

HIV Infections


Study Arms / Comparison Groups

 High-grade disease
Description:  Those who had histologic anal high-grade disease.

Publications

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

Recruitment Information



Estimated Enrollment

401

Start Date

August 2002

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        Inclusion Criteria:

          -  HIV-infected men,

          -  History of anal receptive intercourse,

          -  Minimum age 18 years.

        Exclusion Criteria:

          -  Known anal cancer,

          -  Bleeding diathesis that might preclude anoscopy and biopsy.
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Irving E Salit, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00188292

Organization ID

REB #02-0325-B

Secondary IDs

#016005

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto

Collaborators

 Ontario HIV Treatment Network

Study Sponsor

Irving E Salit, MD, Principal Investigator, Toronto General Hospital


Verification Date

March 2016