Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-15 @ 2:06 AM
Study NCT ID:
NCT02631720
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLAD Phenotype Specific Risk Factors and Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D018962', 'term': 'Phlebotomy'}, {'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral whole blood samples: DNA, RNA, Plasma, Serum Bronchoalveolar lavage (BAL): aliquots with DNA, cells, supernatant'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 884}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).', 'timeFrame': '90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)', 'description': 'First occurrence of either phenotype.'}], 'secondaryOutcomes': [{'measure': 'Longitudinal Quality of life (QOL) trajectory', 'timeFrame': 'Baseline until study completion or participant withdrawal (up to 4 years post-transplant)', 'description': "As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ)"}, {'measure': 'Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins', 'timeFrame': 'Baseline until study completion or participant withdrawal (up to 4 years post-transplant)', 'description': 'Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Lung Allograft Dysfunction (CLAD)', 'Restrictive chronic lung allograft dysfunction (RCLAD)', 'Bronchiolitis Obliterans Syndrome (BOS)', 'CLAD risk factors', 'observational study'], 'conditions': ['Lung Transplant', 'Post Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '39470452', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT)'}, {'url': 'http://www.ctotstudies.org/', 'label': 'Clinical Trials in Organ Transplantation (CTOT)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe purpose of this study is to help doctors determine:\n\n* why some people get CLAD and others do not\n* how patients who get CLAD do after CLAD is diagnosed\n* how CLAD may affect quality of life', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult lung transplant recipients undergoing lung transplant at each of the participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals who meet all of the following criteria are eligible for enrollment as study participants:\n\n1. Subject must be able to understand and provide written informed consent and\n\n -Must be ≥18 years of age at the time of written informed consent.\n2. Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.\n\n \\- Enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (BAL) sampling.\n3. Undergoing first lung transplant operation.\n4. Transplant surgery to be performed or performed at enrolling center.\n\n * Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for enrollment as study participants:\n\n1. Multi-organ recipient.\n2. Prior recipients of any solid organ transplant, including prior lung transplant.\n3. Prior or concurrent recipient of bone marrow transplant.\n4. HIV infection.\n5. Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.\n6. Participation in an investigational drug trial at the time of enrollment visit.'}, 'identificationModule': {'nctId': 'NCT02631720', 'briefTitle': 'CLAD Phenotype Specific Risk Factors and Mechanisms', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)', 'orgStudyIdInfo': {'id': 'DAIT CTOT-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult Lung Transplant Recipients', 'description': 'Adult lung transplant recipients undergoing lung transplant at each of the participating centers.', 'interventionNames': ['Procedure: Blood Draw', 'Procedure: Bronchoscopy']}], 'interventions': [{'name': 'Blood Draw', 'type': 'PROCEDURE', 'otherNames': ['Phlebotomy', 'Venipuncture'], 'armGroupLabels': ['Adult Lung Transplant Recipients']}, {'name': 'Bronchoscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['Adult Lung Transplant Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Scott M Palmer, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'John Belperio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Clinical Trials in Organ Transplantation', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}