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 is ongoing, but not recruiting participants.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00955591
First received: August 7, 2009
Last updated: July 27, 2012
Last verified: July 2012
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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 Other: cytology specimen collection procedure Procedure: biopsy Procedure: diagnostic endoscopic procedure Procedure: histopathologic examination |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label 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 [ Designated as safety issue: No ]
- Comparison of the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab vs a Dacron swab [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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 |
| Genders 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
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
Investigators
| Principal Investigator: | Dorothy Wiley, Ph.D. RN | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00955591 History of Changes |
| Other Study ID Numbers: | CDR0000643881, P30CA016042, UCLA-0901062, IRB# 09-01-062-02 |
| Study First Received: | August 7, 2009 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
human papilloma virus infection anal cancer HIV infection |
Additional relevant MeSH terms:
|
Anus Neoplasms Precancerous Conditions 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 February 26, 2013
