Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
884 participants
OBSERVATIONAL
2015-12-22
2019-11-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Blood Draw
Bronchoscopy
Interventions
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Blood Draw
Bronchoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Clinical Trials in Organ Transplantation
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Scott M Palmer, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University
John Belperio, MD
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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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
Countries
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References
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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.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
Clinical Trials in Organ Transplantation (CTOT)
Other Identifiers
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DAIT CTOT-20
Identifier Type: -
Identifier Source: org_study_id