Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-29 @ 2:45 AM
Study NCT ID:
NCT05426720
Status:
RECRUITING
Last Update Posted:
2022-06-22
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors and Biomarkers for Post-tuberculosis Lung Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], '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'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-11', 'size': 248581, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-10T19:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum cytokines including IL-6, IL-8, MMP and etc will be detected at baseline prior to TB treatment.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung function', 'timeFrame': 'half a year, 1 year, 2 year, and 3-year follow-up', 'description': 'Forced expiratory volume (FEV1, l/min), and forced vital capacity (FVC,l/min) are the important parameters in lung function. FEV1/FVC, diffusing capacity for carbon monoxide (DLCO), and other indicators, will also be observed during follow-up.'}], 'secondaryOutcomes': [{'measure': 'Absorption of TB lesions on lung CT scans after TB treatment', 'timeFrame': 'half a year, 1 year, 2 year, and 3year follow-up', 'description': 'Chest CT images will be interpreted by a respiratory physician and a radiologist. Parenchymal and airway lesions detected on CT scans will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-tuberculosis lung damage', 'cigarette smoking'], 'conditions': ['Pulmonary TB']}, 'descriptionModule': {'briefSummary': 'This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.', 'detailedDescription': 'Introduction: Post-tuberculosis lung damage (PTLD) refers to residual pulmonary impairment following the completion of tuberculosis (TB) treatment, characterized by persistent respiratory symptoms and abnormal pulmonary function. The risk factors and biomarkers for PTLD have been scarcely investigated. Additionally, it remains unclear whether and to what extent cigarette smoking affects PTLD in patients with TB.\n\nMethods and analysis: This prospective observational study will enroll 400 adult male ever-smoker or never-smoker patients aged 25-60 years, with newly confirmed active TB between 2022 and 2024 from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital. Baseline data (age, smoking history, and smoking pack-years), clinical symptoms, lung functions, and chest CT (computed tomography) findings will be prospectively collected. Respiratory questionnaires, lung function measurements, and chest CT examinations will be completed during follow-up visits at 6 months after the initiation of TB treatment, immediately at the completion of TB treatment, and at 1 year, 2 years, and 3 years after the completion of TB treatment. Peripheral blood samples will be obtained at baseline to measure inflammatory mediators and cytokines in serum. The collected data will be analyzed to determine the incidence of and factors/biomarkers for PTLD after TB treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective observational study will enroll male patients who were newly diagnosed with active TB from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital between January 2022 and December 2024.', 'genderDescription': 'self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale patients aged 25-60 years newly diagnosed with active pulmonary TB.\n\nExclusion Criteria:\n\n1. patients with positive sputum smear or TB culture results;\n2. human immunodeficiency virus-positive patients;\n3. patients infected with multidrug-resistant TB;\n4. patients with malignant neoplasms (e.g., lung cancer) or severe cardiovascular and cerebrovascular diseases;\n5. non-compliant patients who were unable to complete the lung function tests;\n6. patients without lung parenchymal destruction (such as tuberculous pleurisy). -'}, 'identificationModule': {'nctId': 'NCT05426720', 'briefTitle': 'Risk Factors and Biomarkers for Post-tuberculosis Lung Damage', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Risk Factors and Biomarkers for Post-tuberculosis Lung Damage in a Chinese Cohort: Protocol for a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'M2022296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with pulmonary tuberculosis', 'description': 'male patients aged 25-60 with active pulmonary tuberculosis', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention; This study is a observational study. All patients received routine anti-tuberculosis regimen. Researchers will observe the clinical manifestation, pulmonary function and pulmonary CT manifestation within a few years after the cure of tuberculosis.', 'armGroupLabels': ['patients with pulmonary tuberculosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Gai, MD.', 'role': 'CONTACT', 'email': 'gxy81wfl79@163.com', 'phone': '008613522708870'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenli Cao, MD', 'role': 'CONTACT', 'email': 'yangqiang@tsinghua.org.cn', 'phone': '13161220446'}], 'facility': 'Beijing Geriatric Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaoyan Gai, MD', 'role': 'CONTACT', 'email': 'gxy81wfl79@163.com', 'phone': '13522708870'}, {'name': 'Sun', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Yongchang Sun, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Respiratory and Critical Care Department, Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will discuss if the data of individuals after the completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Geriatric Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}