Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men

NCT ID: NCT00955591

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-12

Study Completion Date

2016-10-14

Brief Summary

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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

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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.

Conditions

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Anal Cancer Nonneoplastic Condition Precancerous Condition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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swab test

Group Type OTHER

Papanicolaou test

Intervention Type OTHER

Interventions

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Papanicolaou test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorothy Wiley, Ph.D. RN

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

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UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23595039 (View on PubMed)

Other Identifiers

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UCLA-0901062

Identifier Type: -

Identifier Source: secondary_id

IRB# 09-01-062-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000643881

Identifier Type: -

Identifier Source: org_study_id

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