Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.
Other: Papanicolaou test
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy|
- Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab [ Time Frame: a day ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.
- To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.
OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955591
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Dorothy Wiley, Ph.D. RN||Jonsson Comprehensive Cancer Center|