ZIA CP010158-10455 (ZIA) | |||
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Title | A Study Investigating the Association of Human Papillomavirus (HPV)-Related Bioma | ||
Institution | NCI, Bethesda, MD | ||
Principal Investigator | Castle | NCI Program Director | N/A |
Cancer Activity | N/A | Division | DCEG |
Funded Amount | $43,987 | Project Dates | 02/02/2009 - N/A |
Fiscal Year | 2009 | Project Type | Intramural |
Research Topics w/ Percent Relevance | Cancer Types w/ Percent Relevance | ||
Biochemical Epidemiology (45.0%) Cancer (100.0%) |
Colon/Rectum (100.0%) | ||
Research Type | |||
Exogenous Factors in the Origin and Cause of Cancer Technology and/or Marker Evaluation With Respect to Fundamental Parameters of Method |
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Abstract | |||
To improve detection of anal precancer and cancer, we propose a screening study of 1,000 HIV-positive MSM participating in the Kaiser Permanente Northern California (KPNC) health maintenance program as an extension of our on-going collaborations with KPNC (The HPV Persistence and Progression Cohort and the Cervical Cancer Prevention Activities and Outcomes Study). Under written, informed consent, participating KPNC members will respond to a self-administered risk factor questionnaire and will undergo two anal specimen collections into liquid-based cytology (LBC) medium prior to a digital exam and high resolution anoscopy. Subjects will be asked to self-collect at home into the same LBC buffer and return their specimen in a prepared return envelope to evaluate the utility of self-collection for anal cancer screening. Subjects will be followed annually for two years to collect clinical data. Baseline clinician-collected specimens will be tested in a masked fashion for clinical biomarkers. For reference, clinician-collected specimens will be used to make LBC slides and evaluated by an expert cytopathology laboratory. We will estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and referral rates) for detection of prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed anal precancer (anal intraepithelial neoplasia grade 3) or worse. We will test the self-collected anal specimens by the best molecular test(s) or combination of tests for detection of prevalently-detected AIN3 or cancer as determined from testing the clinician-collected specimens. All MSM will undergo diagnostic procedures at all visits and independent of testing results, which will result in unbiased disease ascertainment. Hence, although this is a research study, we will have a rigorous evaluation of these assays for anal cancer screening and prevention, which could then be adopted into clinical practice. |