? ? Lung disease is an important cause of morbidity and mortality at all ages. There is a pressing need for development and validation of biomarkers to aid in the diagnosis and management of patients with lung disease. In particular, combinations of protein biomarkers that can be obtained non-invasively offer great promise. We propose to establish a multidisciplinary Clinical Proteomics Center in Lung Disease to rapidly develop and validate panels of protein biomarkers that can be used in diagnosis, disease prognostication, and treatment of pediatric and adult lung disorders. ? We will base our program on large, well-characterized pediatric and adult patient populations, and extensive expertise in biomarker research. The Clinical Proteomics Program will consist of a phased model of biomarker development encompassing assay validation through retrospective and prospective clinical validation to large scale application. The phased development strategy has several advantages including careful, expeditious evaluation of novel biomarkers; reduction in panel size to the minimum that is clinically useful; and maximum utilization of previously existing national disease networks.
Our specific aims will be to: 1. Establish a center with five cores (Clinical, Laboratory, Data Management/Biostatistics, Educational, and Administrative) to select, validate, apply and continually improve protein biomarker panels. 2. Develop specific protein biomarker panels aimed at predicting progression of disease, assessing likelihood and significance of exacerbation, and evaluating response to treatment in Chronic Obstructive Pulmonary Disease, Asthma, Acute Lung Injury, Chronic Lung Disease of Infancy, Pulmonary Arterial Hypertension and Cystic Fibrosis. 3. Create a local and national educational and skills development program for MDs, PhDs, MD/PhDs, Laboratory Personnel and Research Coordinators, in Clinical Proteomics and 4. Establish a national resource for investigators interested in developing protein biomarkers of lung disease. ? ?
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