Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
NCT ID: NCT06399302
Last Updated: 2025-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2600 participants
OBSERVATIONAL
2024-09-03
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lung transplant donors and recipients
Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Scott M Palmer, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University School of Medicine, Department of Medicine
Jason D Christie, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Megan L Neely, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University School of Medicine, Department of Biostatistics and Bioinformatics
Locations
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University of California Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York University
New York, New York, United States
Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
University Health Network
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROMISE Study
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00114566
Identifier Type: -
Identifier Source: org_study_id
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