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Anal Cancer Screening Study

DCEG investigators are studying risk of anal cancer in HIV-positive men who have sex with men. They have established a screening cohort study of 1,000 HIV-positive men through the Kaiser Permanente Northern California (KPNC) health maintenance program. Under written, informed consent, participating KPNC members will respond to a self-administered risk factor questionnaire and will undergo two anal specimen collections, using liquid-based cytology (LBC) medium, as well as a digital exam and high resolution anoscopy. Participants will be followed annually for two years to collect follow-up clinical data related to outcomes. Baseline clinician-collected specimens will be tested in a masked fashion for the following clinical biomarkers: 1) carcinogenic HPV DNA in aggregate and individual carcinogenic HPV genotypes; 2) carcinogenic HPV RNA and HPV16/18 RNA; 3) cytogenetic changes (3q, 5p, and 20q amplification); and 4) p16INK4a and Ki-67 immunocytochemical staining. For reference, clinician-collected specimens will be used to make LBC slides and evaluated by an expert cytopathology laboratory. Investigators will estimate the HPV genotype-specific risk and the clinical performance (sensitivity, specificity, positive and negative predictive values, and referral rates) of individual tests and combinations of tests for detection of prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed anal precancer (anal intraepithelial neoplasia grade 3) or worse (=AIN3). All participants will undergo diagnostic procedures at all visits and independent of testing results, which will result in unbiased disease ascertainment.

For more information, contact Nicolas Wentzensen.

Hormonal and Reproductive Epidemiology Branch - Research Areas