Screening for HIV-Associated Anal Cancer (TRACE)

Tracking Information
First Submitted Date	September 9, 2005
First Posted Date	September 16, 2005
Last Update Posted Date	March 8, 2016
Study Start Date	August 2002
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00188292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
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
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	HIV + MSM who had High Resolution Anoscopy
Condition	HIV Infections; Anal Cancer; Anal Dysplasia; Papillomavirus Infections
Intervention	Not Provided
Study Groups/Cohorts	High-grade disease Those who had histologic anal high-grade disease.; Control Those who had less than highgrade histologic anal disease
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: March 4, 2016)	401
Original Enrollment; (submitted: September 9, 2005)	425
Actual Study Completion Date	June 2012
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Canada
Removed Location Countries
Administrative Information
NCT Number	NCT00188292
Other Study ID Numbers	REB #02-0325-B; #016005 ( Other Grant/Funding Number: CANFAR )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University Health Network, Toronto
Study Sponsor	University Health Network, Toronto
Collaborators	Ontario HIV Treatment Network; Canadian Foundation for AIDS Research (CANFAR)
Investigators	Principal Investigator: Irving E Salit, MD Toronto General Hospital
PRS Account	University Health Network, Toronto
Verification Date	March 2016