Oral Cancer Detection Methods in a Community Setting

社区环境中的口腔癌检测方法

• 批准号: 7938045
• 负责人: TARU KINNUNEN
• 金额: $ 60.48万
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938045
• 关键词: Adult; Advisory Committees; Affect; Age; Alcohol consumption; Algorithms; American; Area; Biopsy; Cancer Detection; Cancer Etiology; Cancerous; Cessation of life; Characteristics; Cities; 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、大机遇 (GO)，特别是 NIDCR 感兴趣领域 No.4。口腔癌前病变和恶性病变的检测。口腔癌每年影响超过 30,000 名美国人，并导致约 8,000 人死亡。口腔癌比宫颈癌或黑色素瘤影响更多的美国人，但由于缺乏适当的证据，不建议进行口腔癌筛查。未知因素包括视觉和触觉口腔检查的敏感性和特异性，以及市售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新颖的、高影响力的公共卫生方法，对无症状成年人进行口腔癌筛查。该方法包括 i) 社区风险评估、评估口腔癌重要风险因素的能力，以选择风险较高的人群进行筛查，以及 ii) 基于视觉和触觉检查的筛查方法，有或没有各种市售辅助测试。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，旨在缩短口腔癌诊断从最初表现到组织学确认的时间。通过与马萨诸塞州公共卫生部的密切合作，我们计划在马萨诸塞州不同城镇的 80 个疗养院和 80 个免费餐点中随机抽取样本来实施筛查。在我们的样本中，社会经济地位较低且获得护理机会较少的少数群体和个人所占比例过高。疗养院居民或用餐场所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，还将使用以下辅助方法对具有阳性结果的受试者进行筛查：跨上皮刷活检、使用甲苯氯铵的化学发光、组织荧光和光学相干断层扫描。具有口腔癌前病变或癌症阳性体征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之外，我们还计划通过在数据包络分析中保持输入（人力、货币资源等）恒定的同时最大化输出（可疑病变的识别）的功能来评估高风险评估算法对提高筛查效率的影响。 公共卫生相关性：本申请响应 RFA -OD-09-004、大机遇 (GO)，特别是 NIDCR 感兴趣领域 No.4。口腔癌前病变和恶性病变的检测。我们建议评估口腔癌筛查新方法的实用性、效率和临床特征，该方法基于社区风险评估以及使用视觉和触觉检查方法，并辅以市售诊断辅助工具。