Efficacy of Oral Cancer Screening Adjunctive Techniques

口腔癌筛查辅助技术的功效

• 批准号: 7854096
• 负责人: MARK W. LINGEN
• 金额: $ 77万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7854096
• 关键词: Address; Advisory Committees; Affect; Area; Cancer Detection; Chicago; Clinical Research; Clinical Trials Design; Clinical and Translational Science Awards; Communication; Communities; Community Networks; Computer Systems; Consent; Data; Data Collection; Dental; Dental General Practice; Detection; Devices; Diagnosis; Disease; Early Diagnosis; Enrollment; Ensure; Evaluation; Florida; General Population; Goals; Guidelines; Image; Institution; Lesion; Malignant - descriptor; Malignant Neoplasms; Manuals; Medical; Minority; Monitor; National Institute of Dental and Craniofacial Research; New York; Oral; Oral Examination; Oral mucous membrane structure; Oropharyngeal; Outcome; Participant; Patients; Population; Population Heterogeneity; Premalignant; Preventive; Primary Health Care; Procedures; Progress Reports; Provider; Public Health; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recommendation; Recovery; Research; Research Design; Research Infrastructure; Risk; Safety; Sample Size; Screening for Oral Cancer; Screening procedure; Secondary Prevention; Services; Site; Standardization; Study Subject; Tactile; Techniques; Texas; Third-Party Payer; Time; Tissue Banking; Tissue Banks; Training; Treatment Protocols; United States; Universities; Visual; Washington; Work; Writing; base; cost effectiveness; data management; data sharing; design; diagnostic accuracy; follow-up; high risk; improved; malignant mouth neoplasm; pharynx squamous cell carcinoma; practice-based research network; public health relevance; treatment planning; trial comparing

DESCRIPTION (provided by applicant): This application addresses Recovery Act Limited Competition: Research and Research Infrastructure "Grand Opportunities" (GO) (RC2): NIDCR guidelines, RFA-OD-09-004: Area of Scientific Priority 4) Detection of Oral Premalignant and Malignant Lesions. This proposal will compare the diagnostic accuracy of three screening regiments for oral pre-malignant and malignant lesions: conventional oral and tactile examination and conventional exam plus one of two adjunctive devices. This study will be particularly informative because it will be conducted both in communities disproportionately affected by oral cancer, and in patients, similar to those found in private dental practices, who are likely at lower risk of developing pre-malignant or malignant lesions. We also believe that our multi-center approach involving Practice based research networks (PBRN) (to ensure participation of practicing clinicians) and Clinical and Translational Science Awards (CTSA) (to work within an established network of community, academic and public health partners) will help to successfully address many of the challenges that arise in community-based research. Specific Aims: Specific Aim #1: Design a multi-center randomized controlled clinical trial to estimate and compare the diagnostic accuracy of three screening regimens: a) visual and tactile oral examination, b) visual and tactile oral examination + Velscope, and c) visual and tactile oral examination + Trimara OCS 3000. Specific Aim #2: Develop a tactical plan for the safe, rapid and rigorous execution and analysis of the proposed trial. Specific Aim #3: Write a detailed Manual of Procedures (MOP) for conducting the proposed trial. PUBLIC HEALTH RELEVANCE: It has been postulated that the addition of commercially available adjunctive screening devices to the conventional visual and tactile exam will aid in the identification of premalignant or early malignant lesions. However, the incremental benefit in terms of increasing diagnostic accuracy as well as the cost effectiveness of these devices has not been adequately evaluated. Furthermore, it is unknown if these devices will be most useful when they are applied to general and/or high risk populations. In addition, their utility may vary among different ethnic populations. A rigorous evaluation of these devices would inform dental and medical professionals, third-party payers, and the public regarding their value and appropriate use. Our goal is to develop a comprehensive plan to conduct a large multi-center trial that will primarily compare visual and tactile oral mucosal examination with screening device-assisted examination as performed by primary care providers in diverse populations, including minorities.

描述（由申请人提供）：本申请涉及《恢复法案》限制竞争：研究和研究基础设施“大机会”（GO）（RC 2）：NIDCR指南，RFA-OD-09-004：科学优先领域4）口腔癌前病变和恶性病变的检测。本提案将比较三种筛查方案对口腔癌前病变和恶性病变的诊断准确性：常规口腔和触觉检查和常规检查加两种诊断设备之一。这项研究将特别提供信息，因为它将在受口腔癌影响不成比例的社区和患者中进行，与私人牙科诊所中发现的患者相似，这些患者可能发生癌前病变或恶性病变的风险较低。我们还相信，我们的多中心方法涉及基于实践的研究网络（PBRN）（以确保执业临床医生的参与）和临床和转化科学奖（CTSA）（在社区，学术和公共卫生合作伙伴的既定网络内工作）将有助于成功解决社区研究中出现的许多挑战。具体目标：具体目标1：设计一项多中心随机对照临床试验，评估并比较三种筛查方案的诊断准确性：a）视觉和触觉口腔检查，B）视觉和触觉口腔检查+ Velscope，c）视觉和触觉口腔检查+ Trimara OCS 3000。具体目标#2：制定一个战术计划，以安全、快速和严格地执行和分析拟议的试验。具体目标#3：编写一份详细的程序手册（MOP），用于执行拟议的试验。 公共卫生关系：据推测，在传统的视觉和触觉检查中加入市售的连续筛查设备将有助于识别癌前病变或早期恶性病变。然而，尚未充分评价这些器械在提高诊断准确性方面的增量效益以及成本效益。此外，尚不清楚这些器械在应用于一般和/或高风险人群时是否最有用。此外，它们的效用在不同族裔人口中可能有所不同。对这些设备进行严格的评估将使牙科和医疗专业人员、第三方付款人和公众了解它们的价值和适当使用。我们的目标是制定一个全面的计划，进行一项大型多中心试验，主要比较视觉和触觉口腔粘膜检查与初级保健提供者在不同人群（包括少数民族）中进行的筛查设备辅助检查。