Recruiting

Lung Transplant

Sponsor:

Duke University

Code:

NCT06399302

Conditions

Lung Transplant; Complications

Lung Transplant; Infection or Inflammation

Lung Transplant Rejection

Lung Transplant Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lung Transplant; Complications

Lung Transplant; Infection or Inflammation

Lung Transplant Rejection

Lung Transplant Failure

Study ID

NCT06399302

Start date

Sep 3, 2024

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2600 participants

Anticipated

Interventions and Outcome Measures

Arms

Lung transplant donors and recipients

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

Primary outcome measure

  • Number of participants enrolled and critical variable completeness [ Time Frame: 3 years ]
  • Number of PROs collected per patient [ Time Frame: 3 years ]
  • Number of specimens per participant collected [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

John Belperio

University of California at San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Mykah D. Llaguno Dela Rima

mydela1@stanford.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Juan Fernandez Castillo

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Principal Investigator:

Christian Merlo

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Hilary Goldberg

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator:

Stephen Huddleston

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Stephanie Chang

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Luke Benvenuto

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Jason Christie

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Contacts

Principal Investigator:

John McDyer

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Lorraine Ware

Houston Methodist Hospital, Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Howard J. Huang, MD

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Shambhu Aryal

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

Michael Mulligan

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Erin Lowery

University Health Network

Recruiting

Toronto, Canada, Canada

Contacts

Principal Investigator:

Shaf Keshavjee

More Information

Sponsor

Duke University

Last update posted

Aug 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-07.