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Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955591
First Posted: August 10, 2009
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
August 7, 2009
August 10, 2009
February 17, 2017
March 12, 2009
December 12, 2011   (Final data collection date for primary outcome measure)
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab [ Time Frame: a day ]
  • Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
  • Comparison of the number and type-specific identification for human papilloma virus derived from specimens collected by a flocked nylon swab vs a Dacron swab
Complete list of historical versions of study NCT00955591 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Anal Cancer
  • Nonneoplastic Condition
  • Precancerous Condition
Other: Papanicolaou test
swab test
Intervention: Other: Papanicolaou test
Wiley DJ, Hsu H, Bolan R, Voskanian A, Elashoff D, Young S, Dayrit R, Barman P, DeAzambuja K, Masongsong EV, Martínez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 14, 2016
December 12, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00955591
CDR0000643881
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0901062
IRB# 09-01-062-02
Yes
Not Provided
Not Provided
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Dorothy Wiley, Ph.D. RN Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP