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 1, 2 and 3. 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 protocol is designed to approximate the best available strategies for diagnostic assessment and therapy of idiopathic pulmonary fibrosis and sarcoidosis.
The specific aims are: 1. To manage the clinical studies involving patients with idiopathic pulmonary fibrosis and sarcoidosis * Identity eligible patients * Coordinate patient flow from the Fibrotic Lung Disease Network physicians to UMMC for initial evaluation * Obtain informed consent and enroll patients * Collect clinical data * Perform physiologic testing * Score chest roentgenograms and high resolution computerized tomography (HRCT) * Select the biopsy site based on HRCT findings * Communicate biopsy sites to thoracic surgeons at UMMC and at Fibrotic Lung Disease Network sites * Manage outpatients on prednisone and prednisone/azathioprine and methotrexate * Coordinate outpatient management of patients on prednisone, prednisone/azathioprine and methotrexate therapy being followed in the Fibrotic Lung Disease Network 2. To procure tissues and cells for individual investigators * Perform bronchoalveolar lavage (BAL) and transbronchial biopsies (TBBx) in IPF and sarcoidosis patients and BAL in normal volunteers * Collect open lung biopsy specimens from UMMC * Coordinate the procurement of open lung biopsy specimens from patients identified by physicians in the Fibrotic Lung Disease Network * Coordinate the delivery of open lung biopsy specimens from Fibrotic Lung Disease Network to Tissue Core * Procure pulmonary tissues from patients undergoing autopsy or thoracotomy for reasons other than IPF 3. To provide data management services to individual investigators * Organize and manage the clinical data base * Advise on study design, sample size calculations and selection of appropriate outcome variables * Assist with statistical applications and data analysis
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