Limited Competition: Clinical Trials in Organ Transplantation in Children (CTOT-C): Mechanistic Ancillary Studies (U01)

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This Funding Opportunity Announcement (FOA) solicits applications from currently funded Program Directors/Principal Investigators, Mechanistic Subcommittee members, core laboratory leaders and clinical site leaders in the "Clinical Trials in Organ Transplantation in Children (CTOT-C)" Program to support the conduct of studies of immune mechanisms using samples and clinical data collected from pediatric solid organ transplant recipients obtained in (a) ongoing or completed CTOT-C clinical studies, or (b) from other clinical trials in which the samples and data were collected with a demonstrably similar level of investigational rigor. Research supported under this FOA will focus on understanding graft dysfunction and/or loss and immune-mediated morbidity and mortality in pediatric transplant recipients. This FOA will leverage the samples and data gathered from CTOT-C's unique cohort of well-characterized patients, as well as the consortium infrastructure to carry out timely hypothesis-driven mechanistic studies. Successful ancillary mechanistic investigations will enhance the value of ongoing and completed CTOT-C projects, improve the research community's understanding of pediatric transplantation, and contribute to the identification of novel and robust surrogate endpoints for future interventional trials and/or novel therapeutic targets and biomarkers for diagnosis, treatment, and disease monitoring.

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