Screening for HIV-Associated Anal Cancer (TRACE)

This study has been completed.
Sponsor:
Collaborators:
Ontario HIV Treatment Network
Canadian Foundation for AIDS Research (CANFAR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188292
First received: September 9, 2005
Last updated: March 14, 2007
Last verified: March 2007
  Purpose

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.


Condition
HIV Infections
Anal Cancer
Anal Dysplasia
Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Screening for HIV-Associated Anal Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 425
Study Start Date: August 2002
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  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: NCT00188292

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Ontario HIV Treatment Network
Canadian Foundation for AIDS Research (CANFAR)
Investigators
Principal Investigator: Irving E Salit, MD Toronto General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188292     History of Changes
Other Study ID Numbers: REB #02-0325-B, CANFAR #016005
Study First Received: September 9, 2005
Last Updated: March 14, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Human Papillomavirus
Anal
Cancer screening
Immunodeficiency
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Anus Neoplasms
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
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
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014