Lung Tissue Research Consortium (LTRC): Clinical Centers

The National Heart, Lung, and Blood Institute (NHLBI) is seeking Clinical Centers (CCs) for a four-year continuation of the multi-center Lung Tissue Research Consortium (LTRC). The purpose of this announcement is to provide a Presolicitation Notice for the release of the LTRC Solicitation NIH-NHLBI-HR-11-12. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The overall objective of the LTRC is to enable better management of lung diseases by increasing understanding of the pathogenetic mechanisms of these diseases through studies of human lung tissues. The LTRC facilitates histopathological and molecular research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the Consortium. Collections of specimens are linked to extensive, individual clinical and phenotypic data. The LTRC will consist of multiple Clinical Centers (CCs), a Radiology Center (RC), a Tissue Repository (TR), a Data Coordinating Center (DCC), and possibly, External Contributors through the DCC contract. The CCs will enroll subjects and perform extensive clinical phenotyping. The RC will perform quantitative analyses and archiving of high resolution chest computed tomography (CT) images. The TR will process tissues and prepare specimen collections in accordance with investigator requests. The DCC will manage the study and a central database, provide data quality assurance, and coordinate the review and approval of requests for tissues and data. External Contributors, if used, will submit data and biospecimens collected according to the LTRC protocol from individuals with specific, targeted conditions. The NHLBI anticipates multiple awards under a Request for Proposal (RFP) for the Clinical Centers (CCs). The CCs will 1) obtain and maintain approval for CC activities described in the LTRC Protocol Manual; 2) have expertise in pulmonary diseases and participate fully in the activities of the Steering Committee; 3) obtain and maintain training of appropriate staff in LTRC protocols and procedures; 4) identify potential donor subjects, collect screening data necessary to determine eligibility for participation, recruit and enroll the number of donor subjects prescribed, and perform clinical testing and collect donor subject data; 5) procure biological specimens from enrolled donor subjects, perform initial specimen processing, and transmit processed biological specimens to the Tissue Repository; 6) acquire CT images, de-identify the images, and transmit to the Radiology Center; 7) perform quality control and quality assurance activities; 8) report adverse events; 9) identify any problems with existing LTRC procedures and devise strategies to improve procedures; 10) participate with other LTRC investigators in up to two collaborative clinical research substudies; and, 11) conduct approved research studies and disseminate the results and conclusions to the research community. This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about January 8, 2010. This advertisement does not commit the Government to award a contract.