Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection, Lung Transplant Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study
Overview
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.
Primary outcome measures
- Number of participants enrolled and critical variable completeness [Time frame: 3 years]
- Number of PROs collected per patient [Time frame: 3 years]
- Number of specimens per participant collected [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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/exclusion criteria.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- University of California Los Angeles — Los Angeles
- University of California at San Francisco — San Francisco
- Stanford University Medical Center — Stanford
- University of Miami — Miami
- Johns Hopkins University — Baltimore
- Brigham and Womens Hospital — Boston
- University of Michigan — Ann Arbor
- University of Minnesota — Minneapolis
- … and 10 more centers
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT06399302 · Pro00114566 · U24HL163122 · PROMISE Study