The Biomarker Development Laboratory at Moffitt (BeDLAM) combines an outstanding group of scientific investigators already successful in describing a promising biomarker (hnRNP A2/B1) and bringing the marker forward to clinical trial, with excellent support mechanisms (Screening infrastructure, Epidemiology/ Biostatistics Core, Pathology Core/tissue access, SPORE affiliation and established CRADA interactions among Moffitt, the NCI and industry). BeDLAM strengthens existing programs at Moffitt by providing a mechanism for the systematic evaluation of additional promising biomarkers of carcinogenesis. Two new markers from the Tockman Lab (a difucosylated ceramide, lacto-N-fucopentose III, and a microsatellite panel), one from the Shaw lab (p16 Methylation Specific PCR assay) and four markers from the Antonia lab (Transforming growth factor beta receptor Type II, SMAD 2, SMAD 4 and SMAD 7) will be evaluated in BeDLAM. Promising markers will undergo rigorous epidemiologic/biostatistical review. Finally, successful markers will be applied to archived sputum specimens collected during the ongoing Moffitt Cohort screening trial Markers of Transformation in Airways Epithelial Cells from a Cohort of Obstructed Smokers and Former Smokers. This archive will provide preclinical material with subsequent known cancer outcome for final biomarker case-control assay. This final assay will be conducted on a high-throughput screening platform currently under development by our CRADA (Collaborative Research and Development Agreement number 447) industrial partner. Detailed progress of markers through this system will be shared with the NCI-BDL steering committee.