About this trial
This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and provide informed consent
≥ 18 years of age at the time of written informed consent
Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days
Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/
Disqualifiers
Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol
Pregnancy or plans to become pregnant
Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial population
Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of participants enrolled and critical variable completeness
To collect detailed clinical data, blood samples (including DNA), and PROs in 2,600 lung transplant candidates, donors, and recipients across the participating LTC centers to create a robust resource that will support a broad range of additional future clinical and translational research objectives
Number of PROs collected per patient
To collect clinical data and PROs that will specifically support future research studies to determine how variation in donor, surgical, or medical management practices across the participating LTC centers are associated with specific differences in relevant clinical outcomes such as PGD, AR, AMR, ALAD, post-transplant infections, PROs including health-related quality of life, or one-year survival.
Number of specimens per participant collected
To collect clinical data and biosamples that will specifically support future research studies to identify serum biomarkers that are associated with or predict the development of PGD, AR, AMR, ALAD, or CLAD.
Sponsors and contacts
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Duke University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pennsylvania
Collaborator