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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|ClinicalTrials.gov Identifier: NCT00955591|
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : August 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer Nonneoplastic Condition Precancerous Condition||Other: Papanicolaou test||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy|
|Actual Study Start Date :||March 12, 2009|
|Actual Primary Completion Date :||December 12, 2011|
|Actual Study Completion Date :||October 14, 2016|
Other: Papanicolaou test
- Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab [ Time Frame: a day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955591
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Dorothy Wiley, Ph.D. RN||Jonsson Comprehensive Cancer Center|