Lung Transplant Consortium - Clinical Centers (U01 - Clinical Trial Not Allowed)

This Funding Opportunity Announcement (FOA) seeks applications from lung transplant clinical centers (CCs) to form a cooperative multi-site Lung Transplant Consortium (LTC). The LTC will support CCs in conducting observational and complementary mechanistic clinical research studies that aim to understand the impact of site-specific lung transplant selection criteria and clinical management strategies on donor lung utilization and/or early post-transplant outcomes such as the development of primary graft dysfunction (PGD) and acute lung allograft dysfunction (ALAD) in recipients. Each CC application must consist of a multidisciplinary investigative team that includes a lung transplant surgeon and a lung transplant pulmonologist, and be comprised of primary and subsites that have a combined annual lung transplant volume of at least 100 transplants. Each CC application should propose hypothesis-driven scientific questions to assess certain donor and/or recipient clinical practices and their impact on donor lung utilization, PGD, ALAD or other relevant short-term outcomes that can be addressed through observational data and/or biospecimen collection and analysis at the sites included in their application. In addition, the CCs will be expected to enroll participants and contribute to a core set of data and biospecimens to be collected across all participating consortium sites through the implementation of a common research protocol under the auspices of a centralized Data Coordinating Center (DCC) and a Steering Committee (SC). By leveraging this shared longitudinal resource, LTC investigators will have the tools to identify and answer additional important research questions involving lung transplantation. This FOA runs in parallel with a separate FOA that invites applications for the LTC Data Coordinating Center, solicited under RFA-HL-22-003.