The mission of the Clinical Core is to provide the personnel, facilities, and organizational structure necessary to generate the clinical database and patient specimens for Projects 6, 2 and 7. These resources will support individual protocols within the Center, facilitate interactions between investigators, and provide a cohesive framework for the formulation, execution, and data analysis of clinical research projects. The clinical protocols are designed to approximate the best available strategies for diagnostic assessment and therapy for subsets of idiopathic interstitial pneumonias (11P), including idiopathic pulmonary fibrosis (usual interstitial pneumonia, UIP) and nonspecific interstitial pneumonia (NSIP).
The specific aims are to: Manage the clinical studies involving patients with UIP and NSIP including: (a) Identify eligible patients and coordinate patient flow from the Fibrotic Lung Disease Network (FLDN) physicians to the University of Michigan Health System (UN4HS) for initial evaluation (b) Obtain informed consent, enroll patients, collect clinical data (physiologic testing, scoring chest roentgenograms and high resolution computed tomography) (c) Select the biopsy site based on HRCT findings, communicate this to thoracic surgeons at the UMHS and at FLDN sites; coordinate the interpretation of histologic, samples by collaborating pathologists (d) Manage outpatients on prednisone, prednisone/azathiopnine and zileuton at UMBS or the FLDN Procure Tissues and cells for individual investigators including: (a) Performing bronchoalveolar lavage and transbronchial biopsies at appropriate time points (b) Coordinate procurement of surgical lung biopsy specimens at LTMHS or at the FLDN and deliver specimens to appropriate SCOR investigator at the UNIHS Provide data management services to individual investigators including: (a) Organizing and managing the clinical database, advisino on study design, sample size calculation and selection of appropriate outcome variables (b) Assisting with statistical applications and data analysis.
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