Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 9:27 AM
Study NCT ID:
NCT03934034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-05-01
First Post:
2019-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success rate', 'timeFrame': 'Through study completion, at 1 year after treatment start at enrollment', 'description': 'Analysis of treatment success rate according to species of NTM lung disease patients in Korea'}], 'secondaryOutcomes': [{'measure': 'Comparison of the efficacy among different regimens for the treatment of certain species of NTM', 'timeFrame': 'Through study completion, at 1 year after treatment start at enrollment', 'description': 'Comparison of the outcomes measured by culture conversion among different regimens for the treatment of certain species of NTM'}, {'measure': 'Number of participants with changing culture results during treatment', 'timeFrame': 'Through study completion, at 1 year after treatment start at enrollment', 'description': 'Number of participants with changing culture results during treatment'}, {'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'Through study completion, at 1 year after treatment start at enrollment', 'description': 'Number of participants with treatment-related adverse events specifically described in the protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NTM', 'Registry', 'Pulmonary infection'], 'conditions': ['Pulmonary Disease', 'Pulmonary Infection', 'Non-Tuberculous Mycobacterial Pneumonia']}, 'referencesModule': {'references': [{'pmid': '38563246', 'type': 'DERIVED', 'citation': 'Kwak N, Henkle E, Hwang H, Jeon D, Jhun BW, Jo KW, Kang YA, Kim HJ, Kim JY, Kim YR, Kwon YS, Lee JH, Mok J, Park Y, Shim TS, Sohn H, Whang J, Yim JJ. Improvement in Health-Related Quality of Life Following Antibiotic Treatment in Nontuberculous Mycobacterial Pulmonary Disease: Initial Analysis of the NTM-KOREA Cohort. Clin Infect Dis. 2024 Jun 14;78(6):1690-1697. doi: 10.1093/cid/ciae131.'}]}, 'descriptionModule': {'briefSummary': 'The incidence and prevalence of pulmonary disease due to Non-tuberculous mycobacteria (NTM) is increasing worldwide, and this trend has been confirmed in Korea. Treatment of NTM pulmonary disease is difficult and usually requires more than two years of long-term treatment, and the antibiotic regimens used in treatment vary. Therefore, it is difficult to track the natural history of patients with NTM pulmonary disease, to evaluate the treatment outcome, and to understand the effect of specific medicines on the outcome. Establishing a prospective registry of patients with NTM pulmonary disease is expected to accurately evaluate the progress, treatment modality, and treatment outcome of NTM pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with NTM lung disease initiating treatment at each hospital participating in the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of NTM pulmonary disease.\n2. The causative agent of NTM pulmonary disease includes: M. avium complex, or M. abscessus subspecies abscessus, or M. abscessus subspecies massiliense, or M. kansasii.\n3. Patients who starts new treatment (those who have previous history of treatment are eligible)\n\nExclusion Criteria\n\n1. Patients who have been treated for more than 4 weeks.\n2. The causative agent of NTM pulmonary disease is none of M. avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii.'}, 'identificationModule': {'nctId': 'NCT03934034', 'acronym': 'NTM-KOREA', 'briefTitle': 'A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.', 'orgStudyIdInfo': {'id': 'NTM-KOREA'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Korean Institute of Tuberculosis', 'class': 'OTHER'}, {'name': 'International Tuberculosis Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Pulmonary and Critical Care Medicine', 'investigatorFullName': 'Jae-Joon Yim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}