Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
PROMISE
3 other identifiers
observational
2,600
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 7, 2025
July 1, 2025
2.8 years
May 1, 2024
July 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants enrolled and critical variable completeness
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
3 years
Number of PROs collected per patient
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.
3 years
Number of specimens per participant collected
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.
3 years
Study Arms (1)
Lung transplant donors and recipients
Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Eligibility Criteria
Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Pennsylvaniacollaborator
Study Sites (17)
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California at San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
New York University
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
University of Washington
Seattle, Washington, 98109, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
University Health Network
Toronto, Canada
Biospecimen
The DCC will establish the centralized biorepository for the PROMISE-Lung Study at the University of Pennsylvania (Penn). Each specimen will be labeled with the study, sample ID, time-point, specimen type, and a unique barcode ID. Following local site processing, specimens will be locally stored at -80ᵒC at the participating site. Samples will then be batched and shipped on dry ice overnight to Penn at regular intervals. Shipments will be tracked to ensure arrival in a timely manner. Once received at Penn, all biological specimens for the cohort will be scanned into the laboratory information management system (LIMs) and stored at -80ᵒC. Biospecimens sent to Penn will be stored for future research studies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott M Palmer, MD, MHS
Duke University School of Medicine, Department of Medicine
- PRINCIPAL INVESTIGATOR
Jason D Christie, MD, MSCE
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Megan L Neely, PhD
Duke University School of Medicine, Department of Biostatistics and Bioinformatics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2024
First Posted
May 3, 2024
Study Start
September 3, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
July 7, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data from each cycle of an examination or follow-up component are prepared by the DCC and sent to the NHLBI Program Officer for distribution no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first.
- Access Criteria
- The overall governance of the protocol is under the guidance of the NHLBI and the steering committee, composed of members of the DCC and UO1 site representatives. Future studies using these sample will be governed by an ancillary committee of the steering committee. In addition, further analysis using this data may occur via ancillary studies that are submitted separately for IRB review. https://biodatacatalyst.nhlbi.nih.gov/ https://biolincc.nhlbi.nih.gov/home/
After the study is completed, information about the study, including study data, will be submitted to the NIH data repository. NHLBI's BioData Catalyst will be used for data, and BioLINCC will be used for biosample deposition after study completion.