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.
Full Title of Study: “Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Screening
- Masking: None (Open Label)
- Study Primary Completion Date: December 12, 2011
- 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.
- Other: Papanicolaou test
Arms, Groups and Cohorts
- Other: swab test
Clinical Trial Outcome Measures
- Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
- Time Frame: a day
Participating in This Clinical Trial
- HIV-infected or -uninfected adult men who have sex with men
- Concurrent enrollment in the Multicenter AIDS Cohort Study required
- history of anal perforation or other medical contraindications
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Dorothy Wiley, Ph.D. RN, Principal Investigator, Jonsson Comprehensive Cancer Center
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