Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-03-11 @ 2:50 PM
Study NCT ID:
NCT05678166
Status:
UNKNOWN
Last Update Posted:
2023-01-19
First Post:
2022-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Soluble Programmed Death-1 in Predicting Progression of Nodular-bronchiectatic Form of Nontuberculous Mycobacterial Lung Disease: a Multi-Country Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma soluble PD-1 on NTM-LD diagnosis', 'timeFrame': 'within 2 years'}, {'measure': 'Mortality', 'timeFrame': 'within 2 years', 'description': 'Mortality, patient die within 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nontuberculous Mycobacterial Lung Disease']}, 'descriptionModule': {'briefSummary': 'The incidence of nontuberculous mycobacterial lung disease (NTM-LD) is increasing worldwide and in Eastern Asia. NTM-LD leads significant morbidity and mortality, around 25% within 5 years, but the treatment rate is low because the course of NTM-LD is indolent, especially in nodular-bronchiectatic (NB) form. However, there is no biomarker proven for predicting the progression in NB form of NTM-LD. Recently, it has been reported that the ratio of membrane-form programmed death-1 (PD-1) expressed T cells increased in patients with NTM-LD and it was associated with disease severity and progression. The mechanism has been speculated as a "immune exhaustion". In contrast to PD-1 expressed in cell membrane, soluble-form PD-1 is another biomarker that can be easily detected in serum. We recently reported that soluble PD-1 significantly correlated with cavitary lesion and disease progression in patients with NB-form NTM-LD in Taiwan. However, this has not been validated in other countries and ethnicities. Furthermore, the usefulness of soluble PD-1 in diagnosis and predicting mortality warrants further studies.', 'detailedDescription': 'The incidence of nontuberculous mycobacterial lung disease (NTM-LD) is increasing worldwide and in Eastern Asia. NTM-LD leads significant morbidity and mortality, around 25% within 5 years, but the treatment rate is low because the course of NTM-LD is indolent, especially in nodular-bronchiectatic (NB) form. However, there is no biomarker proven for predicting the progression in NB form of NTM-LD. Recently, it has been reported that the ratio of membrane-form programmed death-1 (PD-1) expressed T cells increased in patients with NTM-LD and it was associated with disease severity and progression. The mechanism has been speculated as a "immune exhaustion". In contrast to PD-1 expressed in cell membrane, soluble-form PD-1 is another biomarker that can be easily detected in serum. We recently reported that soluble PD-1 significantly correlated with cavitary lesion and disease progression in patients with NB-form NTM-LD in Taiwan. However, this has not been validated in other countries and ethnicities. Furthermore, the usefulness of soluble PD-1 in diagnosis and predicting mortality warrants further studies. Moreover, it is worthwhile to measure soluble PD-1 in bronchoalveolar lavage to explore local immune pathogenesis of NTM-LD. Therefore, we apply this project to investigate the role of soluble PD-1 in NTM-LD through a multi-country cooperation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with NTM-LD at National University Hospital, Taiwan ,Fukujuji Hospital, Japan and Seoul National University, Korea.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years\n* NTM-LD: (N=250) Diagnosis is made on the basis of the guidelines produced by the American Thoracic Society.Patients have pulmonary symptoms with identified chest image and fit with the microbiology criteria.\n* NTM pulmonary colonizers and others: (N=100) Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC or patients infected with NTM other than MAC species.\n* Pulmonary tuberculosis (TB): (N=100) Those with respiratory specimen culture positive for Mycobacterium tuberculosis or typical TB pulmonary pathology.\n* Healthy control (N=50)\n\nExclusion Criteria:\n\n* Patients who have acquired immunodeficiency syndrome'}, 'identificationModule': {'nctId': 'NCT05678166', 'briefTitle': 'Validation of Soluble Programmed Death-1 in Predicting Progression of Nodular-bronchiectatic Form of Nontuberculous Mycobacterial Lung Disease: a Multi-Country Research', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Validation of Soluble Programmed Death-1 in Predicting Progression of Nodular-bronchiectatic Form of Nontuberculous Mycobacterial Lung Disease: a Multi-Country Research', 'orgStudyIdInfo': {'id': '202210007RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NTM-LD', 'description': 'Diagnosis is made on the basis of the guidelines produced by the American Thoracic Society . Briefly, Patients have pulmonary symptoms with identified chest image and fit with the microbiology criteria.'}, {'label': 'NTM pulmonary colonizers and others', 'description': 'Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC or patients infected with NTM other than MAC species.'}, {'label': 'Pulmonary tuberculosis (TB)', 'description': 'Those with respiratory specimen culture positive for Mycobacterium tuberculosis or typical TB pulmonary pathology.'}, {'label': 'Healthy control', 'description': 'Healthy control'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chin-Chung Shu', 'role': 'CONTACT', 'phone': '+886223123456'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chin-Chung Shu', 'role': 'CONTACT', 'email': 'ccshu@ntu.edu.tw', 'phone': '+886-2312-3456', 'phoneExt': '53087'}], 'overallOfficials': [{'name': 'Chin-Chung Shu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}