Clinical trial NCT06399302: Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Official title: Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplant; Complications
Lung Transplant; Infection or Inflammation
Lung Transplant Rejection
Lung Transplant Failure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pennsylvania
First posted: 2024-05-03
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants enrolled and critical variable completeness
timeFrame: 3 years
measure: Number of PROs collected per patient
timeFrame: 3 years
measure: Number of specimens per participant collected
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Medicine, Department of Medicine
name: Scott M Palmer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Jason D Christie, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University School of Medicine, Department of Biostatistics and Bioinformatics
name: Megan L Neely, PhD
role: PRINCIPAL_INVESTIGATOR
References: