QUANTITATION OF NEOPLASIA IN CANCER CHEMOPREVENTION

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The objectives of this research are to perform the basic research into methods and instrumentation to quantitate the development of neoplasia in the context of cancer chemoprevention, using microscopic image analysis methodology. The expected results of Phase I are proof of concept and feasibility, the major design parameters of an instrument, and the confirmation of sample preparation techniques and software algorithm development needs. These results should provide guidelines to enable an instrument to be developed to rapidly and reliably quantitate the development of neoplasia, specifically for cancer chemoprevention testing. Methods of selection of relevant tissue areas for measurement, and improvement of accuracy, reliability and cost of current methods of testing chemopreventive agents are goals of this research. Quantitative measurement and definitions of such current subjective visual assessments as "nuclear grade", "carcinoma in situ" "preneoplastic intraeithelial neoplasia" and other morphologic categories used to assess the severity of microscopic premalignant specimens, will be developed in view of chemopreventive testing needs. PROPOSED COMMERCIAL APPLICATION: The immediate commercial applications of this research relate to selling the developed instrument to special testing laboratories to test the effectiveness of proposed chemopreventive agents, either in animal model studies or in Phase II clinical trials. The long term potential commercial application relates to reference laboratory testing of special "at risk" patient populations who may be using approved or recommended chemopreventive agents.