Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-28 @ 10:12 AM
Study NCT ID:
NCT05477966
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2022-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative culture conversion until 8 weeks after initiation of treatment', 'timeFrame': 'Within 8 weeks of initiating treatment', 'description': 'Conversion from positive tuberculosis culture to negative tuberculosis culture'}, {'measure': 'Time to negative culture conversion', 'timeFrame': 'Within 6 months of initiating treatment', 'description': 'Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture'}, {'measure': 'Treatment outcome including 1) Cure 2) Treatment completion 3) Treatment failure 4) Death 5) Loss of follow-up 6) Unknown', 'timeFrame': 'Within 2 years of initiating treatment', 'description': '1. Cure: confirmed negative culture conversion plus negative culture results from at least one sputum on the month of treatment completion\n2. Treatment completion: confirmed negative culture conversion at least once during treatment\n3. Treatment failure: positive culture results after 4 months of treatment\n4. Death: death during treatment\n5. Loss of follow-up: loss of follow-up during treatment\n6. Unknown'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Tuberculoses', 'Tuberculosis, Pulmonary']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. As a retrospective observational study, data from patients diagnosed with rifampin susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum in 2019 at the participating institutions will be analyzed (up to 900 people).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 900 patients diagnosed with rifampin-susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum between January 1, 2019 and December 31, 2019 at the participating institutions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05477966', 'briefTitle': 'A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress', 'orgStudyIdInfo': {'id': 'H-2206-179-1336'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medical records review', 'type': 'OTHER', 'description': 'The clinical characteristics at the time of diagnosis of rifampin-susceptible pulmonary tuberculosis patients, the Xpert MTB/RIF assay Ct value, the tuberculosis activity score based on AI of the chest image, and treatment results will be collected retrospectively through medical records.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Joon Yim, MD, PhD', 'role': 'CONTACT', 'email': 'yimjj@snu.ac.kr', 'phone': '+82-2-2072-2059'}], 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae-Joon Yim, MD, PhD', 'role': 'CONTACT', 'email': 'yimjj@snu.ac.kr', 'phone': '+82-2-2072-2059'}, {'name': 'Hyung-Jun Kim, MD', 'role': 'CONTACT', 'email': 'dr.hjkim@snubh.org', 'phone': '+82317877844'}], 'overallOfficials': [{'name': 'Jae-Joon Yim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jae-Joon Yim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jae-Joon Yim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}