Lung Transplant; ComplicationsPROMISENCT06399302
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
An observational study of Lung Transplant; Complications and Lung Transplant; Infection or Inflammation, run by Duke University at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection
- How many people
- 2,600 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 3 Sep 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
United States18 sites, 18 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jules Lin, 734-936-5738, juleslin@umich.edu
Nicholas Demchuk, 734-936-3502, demchuni@med.umich.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Joby Matthew, 443-416-7573, jmathe27@jhmi.edu
Kelley Matt, mkelle51@jhmi.edu
- Recruiting
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Nusrath Abdulla, 857-763-8868, nmovvalabdulla@bwh.harvard.edu
Sam Wong, 000-000-0000, swong1@bwh.harvard.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Laurie Snyder, MD, MHS, 919-684-2240, laurie.snyder@duke.edu
Erika Buckley, 919-660-7222, erika.buckley@duke.edu
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Thao-chi Vo, 703-776-8041, thao-chi.vo@inova.org
Edwinia Battle, 703-776-7691, edwinia.battle@inova.org
- Recruiting
Houston Methodist Hospital, Texas Medical Center
Houston, Texas, 77030
Howard J. Huang, MD, (713) 441-5451, hjhuang@houstonmethodist.org
Serene Shaham, 346-238-5653, sashaham@houstonmethodist.org
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Jennifer Perez, 000-000-0000, jsperez@mednet.ucla.edu
Shahrzad Lari, shahrzadlari@mednet.ucla.edu
- Recruiting
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Megan Devereaux, 000-000-0000, mdevereaux@medicine.wisc.edu
Melanie Nelson, 000-000-0000, mmnelson@medicine.wsic.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Moni Lissett, 305-355-5418, ltueros@med.miami.edu
Walter Brauchle, wab105@med.miami.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Adeline Beck, 000-000-0000, westm128@umn.edu
Henry Madden, 612-725-5665, maddel123@umn.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lisa Smithson, 615-875-8253, lisa.smithson@vumc.org
Tansy Gaines, 256-348-1431, tansy.v.gaines@vumc.org
- Recruiting
New York University
New York, New York, 10016
Shushaunna Bennett, 646-630-2408, shushaunna.bennett@nyulangone.org
Cecilia Deterville, cecilia.deterville@nyulangone.org
- Recruiting
Columbia University
New York, New York, 10032
Shreena Patel, 973-722-6835, sp3646@cumc.columbia.edu
Leonor Suarez, 646-528-9006, ls955@cumc.columbia.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica Johnson, 610-731-1661, jessica.johnson@pennmedicine.upenn.edu
Jason Christie
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Ritchie Koshy, 412-802-8624, koshyrg@upmc.edu
Amanda Zeng, 412-383-1818, zengal@upmc.edu
- Recruiting
University of California at San Francisco
San Francisco, California, 94143
Jon Singer, MD, MS, 415-476-6030, jon.singer@ucsf.edu
Legna Betancourt, 415-476-8073, legna.betancourt@ucsf.edu
- Recruiting
University of Washington
Seattle, Washington, 98109
Chelsea Schmitz, 916-247-5438, cschmitz@uw.edu
Michaela Blanchard, 408-834-2141, michejb@uw.edu
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Gundeep S. Dhillon, MD, (650) 723-6381, gdhillon@stanford.edu
Mykah D. Llaguno Dela Rima, mydela1@stanford.edu
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Canada
Sara Grzywnowicz, 000-000-0000, sara.grzywnowicz@uhn.ca
Kseniya Krasyuk, kseniya.krasyuk@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection, Lung Transplant Failure
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant donors and recipients | Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start3 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott M Palmer, MD, MHS, Principal investigator, Duke University School of Medicine, Department of MedicineJason D Christie, MD, MSCE, Principal investigator, University of PennsylvaniaMegan L Neely, PhD, Principal investigator, Duke University School of Medicine, Department of Biostatistics and Bioinformatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399302
- Sponsor's protocol ID
- Pro00114566
- Other IDs
- U24HL163122, PROMISE Study
- Acronym
- PROMISE
- Status last verified
- Jul 2026
- First submitted
- 1 May 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study
- ClinicalTrials.gov ID
- NCT06399302
- Acronym / sponsor ID
- PROMISE / Pro00114566
- Conditions
- Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection, Lung Transplant Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant donors and recipients | – | –Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott M Palmer, MD, MHS principal investigator
Duke University School of Medicine, Department of Medicine
Jason D Christie, MD, MSCE principal investigator
University of Pennsylvania
Megan L Neely, PhD principal investigator
Duke University School of Medicine, Department of Biostatistics and Bioinformatics
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Complications and Lung Transplant; Infection or Inflammation, run by Duke University at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allyn Damman (919-259-4414, allyn.damman@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled and critical variable completeness (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.