Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes

Recruiting

• Conditions: Lung Transplant; Infection or Inflammation; Lung Transplant; Complications; Lung Transplant Failure; Lung Transplant Rejection

• Registration Number: NCT06399302
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-03
• Status Verified: 2024-09
• Study Start: 2024-09-05
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2600

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.

Exclusion Criteria

1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol
2. Pregnancy or plans to become pregnant
3. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States