Screening for HIV-Associated Anal Cancer (TRACE)
|First Received Date ICMJE||September 9, 2005|
|Last Updated Date||March 14, 2007|
|Start Date ICMJE||August 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00188292 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Screening for HIV-Associated Anal Cancer|
|Official Title ICMJE||Screening for HIV-Associated Anal Cancer|
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.
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.
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00188292|
|Other Study ID Numbers ICMJE||REB #02-0325-B, CANFAR #016005|
|Has Data Monitoring Committee||Yes|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Health Network, Toronto|
|Information Provided By||University Health Network, Toronto|
|Verification Date||March 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP