CLAD Phenotype Specific Risk Factors and Mechanisms

This is an observational, prospective, multicenter study of 800 newly transplanted adult,
first lung transplant recipients that will collect longitudinal clinical data, patient
reported quality of life (QOL) data, and serial biological samples to determine the risk
factors, pathophysiology, and manifestations of restrictive chronic lung allograft
dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant
accrual is within three years of study start‐up. The total study duration is five years.
Participants will be followed a minimum of 2 and a maximum of 5 years.

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study
participants:

1. Subject must be able to understand and provide written informed consent and

-Must be ≥18 years of age at the time of written informed consent.

2. Anticipated listing for lung transplantation OR within 45 days of having received a
single or bilateral cadaveric donor lung transplant.

- Enrollment must occur prior to the start of bronchoscopies eligible for research
bronchoalveolar lavage (BAL) sampling.

3. Undergoing first lung transplant operation.

4. Transplant surgery to be performed or performed at enrolling center.

- Note: Concurrent participation in immune monitoring studies or interventional
device trials are permitted.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study
participants:

1. Multi-organ recipient.

2. Prior recipients of any solid organ transplant, including prior lung transplant.

3. Prior or concurrent recipient of bone marrow transplant.

4. HIV infection.

5. Any condition which the investigators feel would make it unlikely for the recipient to
complete follow up procedures or complete the study.

6. Participation in an investigational drug trial at the time of enrollment visit.