Screening for HIV-Associated Anal Cancer

NCT00188292 | Completed DMC

• 2 other identifiers: REB #02-0325-B#016005
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Anal Cancer; Anal Dysplasia; Papillomavirus Infections

Keywords

Human Papillomavirus; Anal; Cancer screening; Immunodeficiency; HIV

Study Arms (2)

High-grade disease

Those who had histologic anal high-grade disease.

Control

Those who had less than highgrade histologic anal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV + MSM who had High Resolution Anoscopy

You may qualify if:

• HIV-infected men,
• History of anal receptive intercourse,
• Minimum age 18 years.

You may not qualify if:

• Known anal cancer,
• Bleeding diathesis that might preclude anoscopy and biopsy.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario HIV Treatment Network: collaborator
• Canadian Foundation for AIDS Research (CANFAR): collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

HIV Infections; Anus Neoplasms; Papillomavirus Infections; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immune System 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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irving E Salit, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2002
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

CA (1)