Clinical Trial Model

Chemoprevention Trials

Bacus Laboratories developed methods to perform digital image tissue and nuclear grading of preinvasive neoplasia in many tissues, including breast, colon, esophagus and prostate.

The figure above illustrates the general method of comparison analysis to assess the severity of neoplastic progression and the effectiveness of treatment response to  chemopreventive agents.  The measured cell sample distribution in red indicates the nuclear grade of cell nuclei from neoplastic specimens before treatment compared to a normal distribution of nuclei shown in green.  A higher nuclear grade indicates a more severe neoplasia for a given sample population.  The mean of the population distribution might be used for example to compare one specimen with another.  The blue distribution indicates post-treatment response, wherein the sampled cell population now more closely resembles a a normal population as measured by the nuclear grade.

The following reference provides more detail on the methodology and results from a chemoprevention trial. “ Bacus J W; Boone C W; Bacus J V; Follen M; Kelloff G J; Kagan V; Lippman S M. Image morphometric nuclear grading of intraepithelial neoplastic lesions with applications to cancer chemoprevention trials.  Cancer Epidemiology, Biomarkers & Prevention 8 (12):1087-94, 1999.”  Also see references 35-42 listed under Publications.