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| Name | Class |
|---|---|
| Beijing Geriatric Hospital | OTHER |
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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.
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.
Methods 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with pulmonary tuberculosis | male patients aged 25-60 with active pulmonary tuberculosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| lung function | 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. | half a year, 1 year, 2 year, and 3-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of TB lesions on lung CT scans after TB treatment | Chest CT images will be interpreted by a respiratory physician and a radiologist. Parenchymal and airway lesions detected on CT scans will be recorded | half a year, 1 year, 2 year, and 3year follow-up |
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Inclusion Criteria:
Male patients aged 25-60 years newly diagnosed with active pulmonary TB.
Exclusion Criteria:
self-representation of gender identity
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Gai, MD | Contact | 13522708870 | gxy81wfl79@163.com | |
| Sun | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Sun, MD | Respiratory and Critical Care Department, Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
We will discuss if the data of individuals after the completion of the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2022 | Jun 10, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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Serum cytokines including IL-6, IL-8, MMP and etc will be detected at baseline prior to TB treatment.
|
| Beijing Geriatric Hospital | Recruiting | Beijing | China |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |