Anal Carcinoma, HIV Infection, Human Papillomavirus Infection
Conditions
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).
Interventions
PROCEDURECytology Specimen Collection Procedure
Undergo anal cytology collection
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome | Baseline | Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability of APTIMA-HPV to predict risk for HG-AIN | Baseline | Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form. |
| Ability of Hybrid-capture 2 to predict risk for HG-AIN | Baseline | Two contingency tables will contrast HPV infection characteristics for APTIMA-HPV \& HC-2 compared to PCR based genotyping using Linear Array assay. Kappa statistics will be estimated to evaluate the observed versus expected agreement between the Linear Array assay (gold standard) \& the findings for APTIMA-HPV \& HC-2, separately. Prevalence estimates for 37 individual HPVs will be estimated from the data; also, for each type, agreement between the NF- \& Dacron protocols for HPV genotypes will be summarized in tabular \& graphical form. |
| Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer. | Up to 3 years | The cost-effectiveness analyses calculate incremental cost-effectiveness ratios (ICERs) comparing two intervention groups/strategies to the current standard of care, Dacron cytology alone. The ICER is the ratio of the difference in the total costs per patient between groups (numerator) versus the difference in quality-adjusted life-years (QALY) between groups (denominator). Specifically, for these analyses, ICERs are separately estimated for best single \& best combination screening algorithm relative to usual care (Dacron-cytology). The analysis focuses on life-time costs. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDorothy Wiley
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed