Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
18 Years
N/A
Male
Anal Cancer, Nonneoplastic Condition, Precancerous Condition
Trial Information
Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
OBJECTIVES:
- 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.
Inclusion Criteria:
- HIV-infected or -uninfected adult men who have sex with men
- Concurrent enrollment in the Multicenter AIDS Cohort Study required
Exclusion Criteria:
- history of anal perforation or other medical contraindications
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
Safety Issue:
No
Principal Investigator
Dorothy Wiley, Ph.D. RN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000643881
NCT ID:
NCT00955591
Start Date:
March 2009
Completion Date:
February 2013
Related Keywords:
- Anal Cancer
- Nonneoplastic Condition
- Precancerous Condition
- human papilloma virus infection
- anal cancer
- HIV infection
- Anus Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| UCLA | Los Angeles, California 90095 |
