Summary

for males ages 18 years and up (full criteria)
healthy people welcome
at UCLA
study started
estimated completion:
Dorothy Wiley (ucla)

Description

Summary

This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

Official Title

Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM

Details

PRIMARY OBJECTIVES:

  1. Evaluate the sensitivity & specificity, predictive positive value (PPV), & predictive negative value (PNV) (test characteristics) & cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), & protein (quality measures) from nylon-flocked (NF)- & Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) & human papillomavirus (HPV)-infections, using randomized-controlled study design.

II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with & without cytology, to predict HG-AIN.

III. Evaluate the cost-effectiveness & relative cost of single- & multiple-test anal cancer screening algorithms.

OUTLINE:

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).

Keywords

Anal Carcinoma HIV Infection Human Papillomavirus Infection Infection Communicable Diseases HIV Infections Papillomavirus Infections Anus Neoplasms Cytology Specimen Collection Procedure Laboratory Biomarker Analysis

Eligibility

For males ages 18 years and up

Inclusion Criteria:

  • Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled

Locations

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States
  • Los Angeles Gay and Lesbian Center accepting new patients
    Los Angeles California 90028 United States

Lead Scientist

  • Dorothy Wiley (ucla)
    Co-Chair, Pilot and Collaborative Translational Clinical Studies Program. Authored (or co-authored) 52 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02816879
Study Type
Interventional
Last Updated