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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation | NETWORK |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Lung Transplant Recipients | Adult lung transplant recipients undergoing lung transplant at each of the participating centers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
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Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| Scott M Palmer, MD, MHS | Duke University | Principal Investigator |
| John Belperio, MD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39470452 | Derived | 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. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D018962 | Phlebotomy |
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Peripheral whole blood samples: DNA, RNA, Plasma, Serum Bronchoalveolar lavage (BAL): aliquots with DNA, cells, supernatant
| Bronchoscopy |
| Procedure |
|
Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays |
| Baseline until study completion or participant withdrawal (up to 4 years post-transplant) |
| 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 |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Clinical Trials in Organ Transplantation (CTOT) | View source |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D003948 | Diagnostic Techniques, Respiratory System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |