The University of Chicago Research Funding

• Principal Investigator: Mark Lingen, DDS, PhD, Associate Professor, Department of Pathology; Committee on Cancer Biology; Committee on Molecular Medicine/MPMM
• Start Date: September 28, 2009
• Total Award Amount: $768,159

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.

Project Description

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.

This award is funded under the American Recovery and Reinvestment Act of 2009, NIH Award number: 1RC2DE020779-01