The overall objective of this program is to support a multicenter case- control study on the potential etiologic factors for sarcoidosis. The cases will also be followed to gain information on the natural history of this disease including risk factors for progression of disease. A steering committee will develop a protocol and manual of operations which will address the most promising hypotheses to be pursued to identify the cause(s) of sarcoidosis. The protocol will include a comprehensive clinical characterization of each participant and determination of markers of immune responsiveness. Participation in a system for banking biological specimens will be required of each clinical center. The clinical coordinating center will collect, manage and analyze the data collected from the clinical centers. The clinical coordinating center will coordinate writing of the protocol and manual of operations, manage the logistics of the biological banking system, be responsible for setting up the data entry procedures and managing the database, be responsible for the logistics of the steering committee and Data and Safety Monitoring Board meetings, and perform the statistical analysis of the final data set. A six year schedule is envisioned as follows: Phase I (12 Months): A collaborative protocol and manual of operations will be developed; Phase II (48 Months): will involve the recruitment and follow-up of cases, patients and recruitment and interviewing of control subjects, and Phase III (12 Months): will involve data analysis.

Agency
National Institute of Health (NIH)
Institute
Division of Lung Diseases (NHLBI)
Type
Research and Development Contracts (N01)
Project #
N01HR056075-008
Application #
6078723
Study Section
Project Start
1995-06-30
Project End
2000-06-29
Budget Start
1999-05-11
Budget End
2000-06-29
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Clinical Trials and Surveys Corporation
Department
Type
DUNS #
City
Owings Mills
State
MD
Country
United States
Zip Code
21117
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Barnard, Juliana; Rose, Cecile; Newman, Lee et al. (2005) Job and industry classifications associated with sarcoidosis in A Case-Control Etiologic Study of Sarcoidosis (ACCESS). J Occup Environ Med 47:226-34
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Newman, Lee S; Rose, Cecile S; Bresnitz, Eddy A et al. (2004) A case control etiologic study of sarcoidosis: environmental and occupational risk factors. Am J Respir Crit Care Med 170:1324-30

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