Background:
Lung transplants can save lives, but the procedure has risks. Some people develop donor-specific antibodies (DSA) after the procedure-that is, their bodies create proteins that treat the new lungs as foreign and mount an immune response against them. This is called rejection. But not everyone who has a transplant develops DSA, and not everyone who has DSA develops rejection. Researchers want to understand why.
Objective:
To collect data to try to find out why some people develop rejection after lung transplants while others do not.
Eligibility:
People aged 18 to 75 years who have progressive lung disease or undergone or may undergo a lung transplant.
Design:
Participants will have clinic visits every 3 to 6 months for up to 4 years. Some visits might require an overnight stay.
Each visit will include multiple tests and procedures:
Physical exam with blood and urine tests. Some blood will be used for genetic testing.
Imaging scans. Participants will have 2 types of scan to get images of their lungs. For one, they will have a contrast agent given through a tube inserted into a vein.
Six-minute walk test. Participants will walk back and forth in a hallway at their own pace. Researchers will check on how their body responds.
Lung function test. Participants will breathe into a tube connected to a machine.
Two other tests are optional:
Bronchoscopy with washings (lavage). A long tube with a light will be threaded down through the participant s nose or mouth and into their lungs.
Endomicroscopy. During the bronchoscopy a tiny camera may be used to take pictures inside the lungs.
...
Stated willingness to comply with study procedures and availability for the duration of the study.
Male or female, aged 18 - 75 years of age.
Have progressive lung disease or undergone or being evaluated for lung transplantation.
Ability of subjects to understand the informed consent document.
None
Adults with lung transplantation, progressive lung disease, or undergoing evaluation for lung transplantation. The population includes: (1) lung transplant recipients across the post-transplant spectrum (stable maintenance, acute rejection, infection, chronic allograft dysfunction), (2) patients with advanced lung disease being evaluated as transplant candidates, and (3) patients with progressive pulmonary disorders that may warrant lung transplant
Cohort
Prospective
Not listed
Multi-omic molecular differences between DSA+ participants who progress to AMR (DSA+/AMR+), and DSA+ participants who do not progress to AMR (DSA+/AMR-), and DSA- participants
Multi-omic molecular differences between participants who progress to CLAD (CLAD+), and no CLAD (CLAD-)
Imaging findings differences (low dose CT, MRI, Confocal Microscopy) between (DSA+/AMR+), (DSA+/AMR-), and DSA- groups.
Imaging findings differences (CT, MRI, Confocal Microscopy): Between CLAD+, and CLAD- participants
Click on the lead sponsor to view all of their trials.
National Heart, Lung, and Blood Institute (NHLBI)
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborator
