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NCT00955591 Clinical 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

Anal Cancer Clinical Trial

Official title:
Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00955591
Other study ID # CDR0000643881
Secondary ID UCLA-0901062IRB#
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2009
Est. completion date October 14, 2016

Study information
Verified date September 2016
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date October 14, 2016
Est. primary completion date December 12, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Papanicolaou test

Locations
Country Name City State
United States UCLA Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab a day
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