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

NCT00955591 | Completed DMC

• 3 other identifiers: CDR0000643881UCLA-0901062IRB# 09-01-062-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Cancer; Nonneoplastic Condition; Precancerous Condition

Keywords

human papilloma virus infection; anal cancer; HIV infection

Outcome Measures

Primary Outcomes (1)

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

  a day

Study Arms (1)

swab test

OTHER

Other: Papanicolaou test

Interventions

Papanicolaou test OTHER

swab test

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected or -uninfected adult men who have sex with men
• Concurrent enrollment in the Multicenter AIDS Cohort Study required

You may not qualify if:

• history of anal perforation or other medical contraindications

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 23595039 DERIVED

MeSH Terms

Conditions

Anus Neoplasms; Precancerous Conditions; Papillomavirus Infections; HIV Infections

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

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; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dorothy Wiley, Ph.D. RN

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: March 12, 2009
• Primary Completion: December 12, 2011
• Study Completion: October 14, 2016
• Last Updated: August 3, 2020

Record last verified: 2016-09

Locations

US (1)