DCEG investigators are studying risk of anal cancer in HIV-positive men who have sex with men. They have established a cohort of 370 HIV-positive men through the Kaiser Permanente Northern California (KPNC) health maintenance program. Under written, informed consent, participating KPNC members responded to a self-administered risk factor questionnaire and underwent two anal specimen collections, using liquid-based cytology (LBC) medium, as well as a digital exam and high resolution anoscopy. Participants were followed annually for two years to collect follow-up clinical data related to outcomes.
Baseline clinician-collected specimens were 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) p16INK4a and Ki-67 immunocytochemical staining. For reference, clinician-collected specimens are being used to make LBC slides and for evaluation by an expert cytopathology laboratory. Investigators are estimating 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).
For more information, contact Nicolas Wentzensen.