Efficacy of Oral Cancer Screening Adjunctive Techniques

描述（由申请人提供）：本申请涉及恢复法案有限竞争：研究和研究基础设施“重大机遇”（GO） （RC2）： 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检测。本提案将比较三个筛查团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辅助设备中的一种。这项研究将提供特别丰富的信息，因为它将在受口腔癌影响不成比例的社区中进行，并且在与私人牙科诊所相似的患者中进行，这些患者发生恶性前病变或恶性病变的风险可能较低。我们还相信，我们的多中心方法，包括基于实践的研究网络（PBRN）（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中工作），将有助于成功解决社区研究中出现的许多挑战。具体目的：具体目的#1：设计一项多中心随机对照临床试验，以评估和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、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）来进行拟议的试验。

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.