Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04078412
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2019-11-18
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registry for Nontuberculous Mycobacterial Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, urine, RNA and DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-09-01', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment outcome based on NTM-NET consensus statement', 'timeFrame': 'At the end of the treatment or 12months after treatment', 'description': "1. For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results\n2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results."}], 'secondaryOutcomes': [{'measure': 'biomarker for disease progression: RNA sequence analysis', 'timeFrame': 'at the beginning of the treatment', 'description': 'exploration for various biomarkers with RNA sequence analysis'}, {'measure': 'biomarker for disease progression: metabolomic analysis', 'timeFrame': 'at the beginning of the treatment', 'description': 'exploration for various biomarkers with metabolomic analysis'}, {'measure': 'biomarker for disease progression: RNA sequence analysis', 'timeFrame': 'at the end of the treatment (through study completion, an average of 12 to 15month after treatment)', 'description': 'exploration for various biomarkers with RNA sequence analysis'}, {'measure': 'biomarker for disease progression: metabolomic analysis', 'timeFrame': 'at the end of the treatment (through study completion, an average of 12 to 15month after treatment)', 'description': 'exploration for various biomarkers with metabolomic analysis'}, {'measure': 'biomarker for monitoring of treatment response: RNA sequence analysis', 'timeFrame': 'at the beginning of the treatment', 'description': 'exploration for various biomarkers with RNA sequence analysis'}, {'measure': 'biomarker for monitoring of treatment response: metabolomic analysis', 'timeFrame': 'at the beginning of the treatment', 'description': 'exploration for various biomarkers with metabolomic analysis'}, {'measure': 'biomarker for monitoring of treatment response: RNA sequence analysis', 'timeFrame': 'at the end of the treatment (through study completion, an average of 12 to 15month after treatment)', 'description': 'exploration for various biomarkers with RNA sequence analysis'}, {'measure': 'biomarker for monitoring of treatment response: metabolomic analysis', 'timeFrame': 'at the end of the treatment (through study completion, an average of 12 to 15month after treatment)', 'description': 'exploration for various biomarkers with metabolomic analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nontuberculous mycobacteria', 'pulmonary', 'cohort'], 'conditions': ['Nontuberculous Mycobacterial Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Background:\n\nNTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.\n\nobjective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.\n\nMethods:\n\n1. informed consents\n2. register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria\n3. follow up 6 months to 1year based on the clinical situation\n\nAnalysis:\n\n1. treatment outcome based on NTM-NET consensus statement\n2. exploration of biomarker for progression and monitoring of treatment response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpaient clinic and hospitalzed patients in tertiary referral hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 20 or more than 20 years\n2. diagnosed by ATS criteria for NTM pulmonary disease\n\nExclusion Criteria:\n\n1\\) not specific'}, 'identificationModule': {'nctId': 'NCT04078412', 'briefTitle': 'A Registry for Nontuberculous Mycobacterial Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease', 'orgStudyIdInfo': {'id': '4-2017-0958'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NTM pulmonary disease', 'description': 'Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}