NCT06399302 · Duke University
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
(PROMISE)
What this study is 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.
View original scientific description
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.
Primary outcome measures
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
- San Francisco, California
- Stanford, California
- Miami, Florida
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- New York, New York
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
And 5 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations