CLAD Phenotype Specific Risk Factors and Mechanisms
A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)
1 other identifier
observational
884
2 countries
5
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedDecember 17, 2019
December 1, 2019
3.9 years
December 14, 2015
December 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
First occurrence of either phenotype.
90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Secondary Outcomes (2)
Longitudinal Quality of life (QOL) trajectory
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
Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
Study Arms (1)
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Interventions
Eligibility Criteria
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California, Los Angeles
Los Angeles, California, 90095, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Toronto
Toronto, Ontario, M5G 2N2, Canada
Related Publications (1)
Todd JL, Weigt SS, Neely ML, Grau-Sepulveda MV, Mason K, Sever ML, Kesler K, Kirchner J, Frankel CW, Martinu T, Shino MY, Jackson AM, Pavlisko EN, Williams N, Robien MA, Singer LG, Budev M, Tsuang W, Shah PD, Reynolds JM, Snyder LD, Belperio JA, Palmer SM. Prognosis and Risks for Probable Chronic Lung Allograft Dysfunction: A Prospective Multicenter Study. Am J Respir Crit Care Med. 2025 Feb;211(2):239-247. doi: 10.1164/rccm.202403-0568OC.
PMID: 39470452DERIVED
Related Links
Biospecimen
Peripheral whole blood samples: DNA, RNA, Plasma, Serum Bronchoalveolar lavage (BAL): aliquots with DNA, cells, supernatant
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott M Palmer, MD, MHS
Duke University
- STUDY CHAIR
John Belperio, MD
University of California, Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
December 16, 2015
Study Start
December 22, 2015
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
December 17, 2019
Record last verified: 2019-12