Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
Primary Purpose
Anal Cancer, Nonneoplastic Condition, Precancerous Condition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Papanicolaou test
Sponsored by
About this trial
This is an interventional screening trial for Anal Cancer focused on measuring human papilloma virus infection, anal cancer, HIV infection
Eligibility Criteria
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
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
swab test
Arm Description
Outcomes
Primary Outcome Measures
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
Secondary Outcome Measures
Full Information
NCT ID
NCT00955591
First Posted
August 7, 2009
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00955591
Brief Title
Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
Official Title
Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 12, 2009 (Actual)
Primary Completion Date
December 12, 2011 (Actual)
Study Completion Date
October 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Nonneoplastic Condition, Precancerous Condition
Keywords
human papilloma virus infection, anal cancer, HIV infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
swab test
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Papanicolaou test
Primary Outcome Measure Information:
Title
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
Time Frame
a day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Wiley, Ph.D. RN
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23595039
Citation
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.
Results Reference
derived
Learn more about this trial
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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