This application responds to RFA -OD-09-004, Grand Opportunities (GO), especially to NIDCR Area of Interest No.4. Detection of Oral Premalignant and Malignant Lesions. Oral cancers affect more than 30,000 Americans every year, and cause approximately 8,000 deaths annually. Oral cancers affect more Americans than cervical cancer or melanoma, yet screening for oral cancer is not recommended due to lack of appropriate evidence. Among the unknowns are the sensitivity and specificity of visual and tactile oral examination, as well as the overall utility of the commercially-available diagnostic aids. Here we propose to test and fine tune a novel, high-impact public health approach of oral cancer screening among asymptomatic adults. The method incorporates i) risk assessment in the community, the ability to assess important risk factors for oral cancer to select population segments at much higher risk to be screened, and ii) a screening method based on visual and tactile examination, with or without various commercially-available adjunctive tests. The long term goal of this project is to gather enough information to design a large community-based clinical trial aimed to reduce the timing of oral cancer diagnosis from initial presentation to histological confirmation. Through a well-established close collaboration with the Massachusetts Department of Public Health we plan to select in random a sample of 80 nursing homes and 80 free-meal sites across a diverse range of Massachusetts cities and towns to implement the screening. Minorities and individuals with low socioeconomic status and reduced access to care will be over-represented in our sample. Nursing home residents or meal site visitors will be asked to participate in a comprehensive on-site examination that includes an interview, and a series of intra-oral examinations. Subjects with positive findings will also be screened with the following adjunctive methods prior to receiving a biopsy: trans-epithelial brush biopsy, chemiluminescence with application of tolonium chloride, tissue fluorescence, and optical coherence tomography. Subjects with positive signs for oral precancer or cancer will be followed up via biopsy;histological confirmation of malignancy or dysplasia will serve as the golden rule in assessing the sensitivity and specificity of the various methods of examination. In addition to calculating the sensitivity and specificity of adjunctive methods we plan to assess the impact of the high-risk assessment algorithm in increasing the efficiency of screening via a function that maximizes outputs (identification of suspicious lesions) while maintaining inputs (manpower, monetary resources etc) constant in Data Envelopment Analysis.
This application responds to RFA -OD-09-004, Grand Opportunities (GO), especially to NIDCR Area of Interest No.4. Detection of Oral Premalignant and Malignant Lesions. We propose to assess the utility, efficiency and clinical characteristics of a novel approach of oral cancer screening that is based on community- based risk assessment and the use of visual &tactile examination methods augmented with commercially available diagnostic aids.