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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

Jonsson Comprehensive Cancer Center logo

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Anal Cancer
Nonneoplastic Condition
Precancerous Condition

Treatments

Other: Papanicolaou test

Study type

Interventional

Funder types

Other

Identifiers

NCT00955591
IRB# 09-01-062-02
CDR0000643881
UCLA-0901062

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

swab test
Other group
Treatment:
Other: Papanicolaou test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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