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Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy


N/A
18 Years
N/A
Open (Enrolling)
Male
Anal Cancer, Nonneoplastic Condition, Precancerous Condition

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Trial Information

Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab

Safety Issue:

No

Principal Investigator

Dorothy Wiley, Ph.D. RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000643881

NCT ID:

NCT00955591

Start Date:

March 2009

Completion Date:

February 2013

Related Keywords:

  • Anal Cancer
  • Nonneoplastic Condition
  • Precancerous Condition
  • human papilloma virus infection
  • anal cancer
  • HIV infection
  • Anus Neoplasms
  • Precancerous Conditions

Name

Location

UCLALos Angeles, California  90095