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

May 7, 2026 updated by: Duke University

Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Estimated)

2600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Toronto, Canada
  • United States
    • California
      • Los Angeles, California, United States, 90095
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California at San Francisco
        • Contact:
        • Contact:
      • Stanford, California, United States, 94305
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Fernandez Castillo
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Merlo
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Stephen Huddleston
        • Contact:
        • Contact:
    • New York
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • John McDyer
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorraine Ware
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital, Texas Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Howard J. Huang, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shambhu Aryal
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Mulligan
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants enrolled and critical variable completeness
Time Frame: 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
3 years
Number of PROs collected per patient
Time Frame: 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.
3 years
Number of specimens per participant collected
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114566
  • U24HL163122 (U.S. NIH Grant/Contract)
  • PROMISE Study (Other Identifier: LTC-DCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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