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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00955591
First received: August 7, 2009
Last updated: February 15, 2017
Last verified: September 2016
  Purpose

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 Intervention
Anal Cancer Nonneoplastic Condition Precancerous Condition Other: Papanicolaou test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

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

Enrollment: 48
Actual Study Start Date: March 12, 2009
Study Completion Date: October 14, 2016
Primary Completion Date: December 12, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
swab test 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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 7, 2009
Last Updated: February 15, 2017

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

ClinicalTrials.gov processed this record on August 16, 2017