SOLICITATION NOTICE
A -- SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS): Clinical Centers
- Notice Date
- 9/10/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NHLBI-HR-08-08
- Archive Date
- 6/30/2008
- Description
- The NHLBI is seeking Clinical Centers (CC) for a new seven-year multi-center clinical research study entitled, Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). Contractors will design and conduct a longitudinal, observational study, with extensive subject phenotyping, to identify subpopulations among patients with chronic obstructive pulmonary disease (COPD) and to identify and validate surrogate markers of disease severity which will be useful as intermediate outcome measures for clinical trials. Secondary aims are to clarify the natural history of COPD, to develop bioinformatic resources that will enable the utilization and sharing of data among studies of COPD and related diseases, and to create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD. Research subjects will be enrolled, phenotyped, and followed at approximately six Clinical Centers. A Genomics and Informatics Center and a Radiology Center will be awarded under separate solicitations. This observational study will collect and analyze phenotypic, biomarker, genetic, genomic, and clinical data from several thousand research subjects with COPD. High throughput genetic, genomic, and proteomic analyses of biospecimens will be performed by core laboratories contracted separately. Baseline data will be analyzed in a cross-sectional manner to identify subpopulations of patients with similar molecular abnormalities. Longitudinal data will be used to identify and validate intermediate outcome measures, such as x-ray computed tomographic (CT) image, biomarker, and genomic measures whose spontaneous changes over a period of 9-12 months correlate with long-term outcomes of mortality, frequency of hospitalizations, change in spirometry, and change in quality of life. Secondary aims are to develop a bioinformatic infrastructure that will enable the utilization and sharing of pulmonary research data and to create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFPs will be available on or about September 20, 2007 at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on FedBizOpps. This advertisement does not commit the Government to award a contract.
- Record
- SN01400661-W 20070912/070910220325 (fbodaily.com)
- Source
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