CLAD Phenotype Specific Risk Factors and Mechanisms
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|ClinicalTrials.gov Identifier: NCT02631720|
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : December 17, 2019
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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
|Condition or disease||Intervention/treatment|
|Lung Transplant Post Lung Transplantation||Procedure: Blood Draw Procedure: Bronchoscopy|
|Study Type :||Observational|
|Actual Enrollment :||884 participants|
|Official Title:||A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)|
|Actual Study Start Date :||December 22, 2015|
|Actual Primary Completion Date :||November 30, 2019|
|Actual Study Completion Date :||November 30, 2019|
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Procedure: Blood Draw
- Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS). [ Time Frame: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant) ]First occurrence of either phenotype.
- Longitudinal Quality of life (QOL) trajectory [ Time Frame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant) ]As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ)
- Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins [ Time Frame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant) ]Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
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.
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.
- Undergoing first lung transplant operation.
Transplant surgery to be performed or performed at enrolling center.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Multi-organ recipient.
- Prior recipients of any solid organ transplant, including prior lung transplant.
- Prior or concurrent recipient of bone marrow transplant.
- HIV infection.
- Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
- Participation in an investigational drug trial at the time of enrollment visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631720
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|University of Toronto|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Scott M Palmer, MD, MHS||Duke University|
|Study Chair:||John Belperio, MD||University of California, Los Angeles|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||December 16, 2015 Key Record Dates|
|Last Update Posted:||December 17, 2019|
|Last Verified:||December 2019|
Chronic Lung Allograft Dysfunction (CLAD)
Restrictive chronic lung allograft dysfunction (RCLAD)
Bronchiolitis Obliterans Syndrome (BOS)
CLAD risk factors