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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

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ClinicalTrials.gov Identifier: NCT00955591
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Anal Cancer Nonneoplastic Condition Precancerous Condition Other: Papanicolaou test

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
Actual Study Start Date : March 12, 2009
Primary Completion Date : December 12, 2011
Study Completion Date : October 14, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
swab test Other: Papanicolaou test


Outcome Measures

Primary Outcome Measures :
  1. Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab [ Time Frame: a day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dorothy Wiley, Ph.D. RN Jonsson Comprehensive Cancer Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00955591     History of Changes
Other Study ID Numbers: CDR0000643881
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0901062
IRB# 09-01-062-02
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: September 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
human papilloma virus infection
anal cancer
HIV infection

Additional relevant MeSH terms:
Disease
Anus Neoplasms
Precancerous Conditions
Pathologic Processes
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases