While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation. The purpose of this study is to help doctors determine: * why some people get CLAD and others do not * how patients who get CLAD do after CLAD is diagnosed * how CLAD may affect quality of life
This is an observational, prospective, multicenter study of 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 four years. Participants will be followed a minimum of 1 and a maximum of 4 years.
Study Type
OBSERVATIONAL
Enrollment
884
University of California, Los Angeles
Los Angeles, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toronto
Toronto, Ontario, Canada
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
First occurrence of either phenotype.
Time frame: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Longitudinal Quality of life (QOL) trajectory
As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins
Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays
Time frame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
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