Oral Cancer Detection Methods in a Community Setting

社区环境中的口腔癌检测方法

• 批准号: 7852960
• 负责人: TARU KINNUNEN
• 金额: $ 60.99万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7852960
• 关键词: Adult; Advisory Committees; Affect; Age; Alcohol consumption; Algorithms; American; Area; Biopsy; Cancer Detection; Cancer Etiology; Cancerous; Cessation of life; Characteristics; Cities; Classification; Clinical; Clinical Trials; Collaborations; Communities; Consent Forms; Data; Detection; Diagnosis; Diagnostic; Dysplasia; Early Diagnosis; Elderly; Epidemiology; Epithelial; Evaluation; Fluorescence; Foundations; Funding; Future; General Population; Goals; Grant; Health; Health Personnel; Health Planning; Health Services Accessibility; Health behavior; Healthcare; Human Resources; Individual; Interview; Knowledge; Laboratories; Lead; Lesion; Letters; Literature; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Massachusetts; Methodology; Methods; Minority; Modeling; National Institute of Dental and Craniofacial Research; Nursing Homes; Optical Coherence Tomography; Oral; Oral Examination; Oral health; Output; Pathology; Policies; Population; Premalignant; Preventive; Primary Health Care; Principal Investigator; Public Health; Research; Research Ethics Committees; Resource Allocation; Resources; Respondent; Risk; Risk Assessment; Risk Factors; Sampling; Screening for Oral Cancer; Screening procedure; Sensitivity and Specificity; Series; Services; Site; Smoke; Tactile; Testing; Time; Tissues; Tolonium chloride; United States; Vision; Visual; Work; base; cancer diagnosis; cancer risk; community setting; cost; design; evidence based guidelines; experience; follow-up; high risk; instrument; interest; low socioeconomic status; malignant mouth neoplasm; melanoma; novel; novel strategies; oral premalignancy; programs; public health relevance; time use; user-friendly

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.

描述（由申请人提供）：本申请响应RFA -OD-09-004，大机会（GO），特别是NIDCR感兴趣的领域4。口腔癌前病变和恶性病变的检测。口腔癌每年影响3万多美国人，每年导致大约8000人死亡。口腔癌对美国人的影响大于宫颈癌或黑色素瘤，但由于缺乏适当的证据，不建议对口腔癌进行筛查。其中未知的是视觉和触觉口腔检查的敏感性和特异性，以及商业上可用的诊断辅助工具的整体效用。在这里，我们建议测试和微调一种在无症状成人中进行口腔癌筛查的新颖、高影响的公共卫生方法。该方法包括i)社区风险评估，评估口腔癌的重要风险因素，以选择风险高得多的人群进行筛查的能力，以及ii)基于视觉和触觉检查的筛查方法，有或没有各种商业上可获得的辅助测试。该项目的长期目标是收集足够的信息来设计一项大型社区临床试验，旨在减少口腔癌的诊断时间，从最初的表现到组织学确认。通过与马萨诸塞州公共卫生部建立良好的密切合作，我们计划在马萨诸塞州不同的城镇中随机选择80个养老院和80个免费膳食点作为样本来实施筛查。在我们的样本中，少数民族和社会经济地位低、获得医疗服务机会少的个人将被过度代表。养老院居民或用餐现场访客将被要求参加全面的现场检查，包括面试和一系列口腔内检查。在接受活检之前，阳性结果的受试者也将使用以下辅助方法进行筛查：跨上皮刷活检，应用氯化甲咯铵的化学发光，组织荧光和光学相干断层扫描。有口腔癌前病变或癌症阳性迹象的受试者将通过活检进行随访；恶性肿瘤或不典型增生的组织学确认将作为评估各种检查方法的敏感性和特异性的黄金法则。除了计算辅助方法的敏感性和特异性外，我们还计划评估高风险评估算法在提高筛查效率方面的影响，该算法通过在数据包络分析中实现输出最大化（识别可疑病变），同时保持投入（人力、财力等）不变。