This is a natural history study designed to identify markers of early malignant transformation that could be used in predicting which oral soft tissues are most likely to lead to oral cancer. Persons with white and or red oral mucosal lesions seen at six Department of Veterans Administration (VA) hospitals will be selected for the study. Study subjects will undergo a biopsy of all suspect oral lesions, provide information about tobacco, alcohol intake, and other habits and re- examined every four months for two years and re-biopsied as appropriate. The biopsy material will be analyzed for the presence or activity of certain molecules thought to be associated with the malignant phenotype including P53-dependent growth suppressers, viral agents, and carcinogen- metabolizing alleles. Statistical analysis will determine associations between molecular markers from the oral lesions and the lesions' histopathology and will examine how environmental, behavioral, and sociodemographic factors influence these associations. If molecules indicative of early transformation can be identified, they may be used to identify persons who should be monitored most closely for the development of oral cancer and to recognize oral cancers at the earliest, most treatable stage. During the past year the study the protocol was finalized and human subjects clearances were obtained in six VA Hospitals. Training materials were prepared and each of the site principal investigators and their assistants were trained. Fieldwork began in the sites, site visits were conducted, and questionnaire and biological materials have begun to be delivered to the Contractor and NIDR.
