LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University
About this trial
This is a prospective, multicenter observational cohort study aimed at establishing a nationwide post-TB lung disease registry in Korea. The study will enroll adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB. Over a five-year follow-up period, the study will assess the long-term health consequences of TB, focusing on respiratory symptoms, radiological changes, pulmonary function, and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years
Diagnosed with pulmonary TB and either initiating or undergoing treatment or history of treated pulmonary TB
Disqualifiers
Age <19 years
Extrapulmonary TB without lung involvement
Refusal to provide informed consent
Trial population
Adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
360 Participants
are grouped into 1 trial groupGroup A: Active TB patients initiating or undergoing treatment or Post-treatment TB survivors
Trial outcomes
Primary outcomes
1
respiratory symptoms
Prevalence and progression of respiratory symptoms (mMRC score, cough, sputum, hemoptysis)
Time frame
6month , 1year, 2year, 3year, 4year, 5year, 6year2
abnormal radiographic findings
abnormal findings of chest X-ray or chest CT
Time frame
6month , 1year, 2year, 3year, 4year, 5year, 6year3
pulmonary function
Pulmonary function measured by spirometry: FEV1, FVC, FEV1/FVC
Time frame
6month , 1year, 2year, 3year, 4year, 5year, 6year4
Quality of life
Quality of life measured by EQ-5D-5L, PROMIS, SGRQ
Time frame
6month , 1year, 2year, 3year, 4year, 5year, 6yearSecondary outcomes
1
poor long-term outcome
Association of poor long-term outcomes with demographic and clinical variables (age, sex, BMI, comorbidities)
Time frame
6month , 1year, 2year, 3year, 4year, 5year, 6yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov