Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
| Registry | NCT00955591 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 48 (Actual) |
| Sponsor | Jonsson Comprehensive Cancer Center (Other) |
| Conditions | Anal Cancer, Nonneoplastic Condition, Precancerous Condition |
| Interventions | Papanicolaou test (Other) |
| Dates | start 2009-03-12, primary completion 2011-12-12, completion 2016-10-14, first posted 2009-08-10, last updated 2020-08-03 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Anal Cancer All trials for Nonneoplastic Condition All trials of Papanicolaou test
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| swab test | Other | Other: Papanicolaou test |
Sex: Male, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| UCLA | Los Angeles, California | United States |