Clinical trial NCT02816879: Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men
Official title: Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anal Carcinoma
HIV Infection
Human Papillomavirus Infection
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2016-06-29
Enrollment: 415
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
timeFrame: Baseline
Secondary outcomes:
measure: Ability of APTIMA-HPV to predict risk for HG-AIN
timeFrame: Baseline
measure: Ability of Hybrid-capture 2 to predict risk for HG-AIN
timeFrame: Baseline
measure: Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Gay and Lesbian Center
state: California
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Palm Springs
country: United States
facility: Desert AIDS Project
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Dorothy Wiley
role: PRINCIPAL_INVESTIGATOR
References: