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

Duke University

Status: Enrolling

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06399302

PROMISE Study (Other Identifier)

U24HL163122 (U.S. NIH Grant/Contract)

Pro00114566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,600 participants in 1 patient group

Lung transplant donors and recipients

Description:

Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients