Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
NCT ID: NCT00955591
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2009-03-12
2016-10-14
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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swab test
Papanicolaou test
Interventions
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Papanicolaou test
Eligibility Criteria
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Inclusion Criteria
* Concurrent enrollment in the Multicenter AIDS Cohort Study required
Exclusion Criteria
18 Years
MALE
Yes
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dorothy Wiley, Ph.D. RN
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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UCLA
Los Angeles, California, United States
Countries
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References
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Wiley DJ, Hsu H, Bolan R, Voskanian A, Elashoff D, Young S, Dayrit R, Barman P, DeAzambuja K, Masongsong EV, Martinez-Maza O, Detels R. Comparison of 2 anal cytology protocols to predict high-grade anal intraepithelial neoplasia. J Low Genit Tract Dis. 2013 Oct;17(4):414-24. doi: 10.1097/LGT.0b013e318281d36e.
Other Identifiers
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UCLA-0901062
Identifier Type: -
Identifier Source: secondary_id
IRB# 09-01-062-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000643881
Identifier Type: -
Identifier Source: org_study_id
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