Lung Transplant; Complications, Lung Transplant Failure, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection
Conditions
Brief summary
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.
Detailed description
This is an observational, prospective, multicenter cohort study of 2,600 lung transplant donors and adult (18 years and older) lung transplant candidates and recipients that will collect longitudinal clinical data, and serial biological (blood) specimens and PROs to support a broad range of clinical and translational future research. Data and biospecimens will be rigorously collected and monitored to ensure high quality future studies that will address unmet needs and optimal management at each stage of the transplant journey from listing, to donor selection, to postoperative management. Subjects are recruited to the study either prior to undergoing lung transplant at the time of listing or within 30 days of having undergone a lung transplant at one of the enrolling centers. The study design will generally follow the SOC practices at each center to minimize additional research related visits. Participants will follow the SOC transplant protocols at each site. Every attempt will be made by the site to collect study data and research specimens from participants at the time of SOC visits. Participation in this study will include scheduled data extraction or data transfers at specified time intervals, serial prospective blood collection (including plasma, serum), recipient DNA sample collection (with donor DNA sample collection optional), and PRO measures.
Interventions
None listed
Sponsors
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand and provide informed consent 2. ≥ 18 years of age at the time of written informed consent 3. 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/
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants enrolled and critical variable completeness | 3 years | 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 | 3 years | 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 | 3 years | 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. |
Countries
Canada, United States
Contacts
CONTACTAllyn Damman
CONTACTCarl Schuler, RN
PRINCIPAL_INVESTIGATORScott M Palmer, MD, MHS
Duke University School of Medicine, Department of Medicine
PRINCIPAL_INVESTIGATORJason D Christie, MD, MSCE
University of Pennsylvania
PRINCIPAL_INVESTIGATORMegan L Neely, PhD
Duke University School of Medicine, Department of Biostatistics and Bioinformatics
Outcome results
None listed