Clinical trial NCT06946784: LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea
Official title: LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Post Tuberculosis
Keywords: post tuberculosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB.

Brief summary: 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.

Detailed description: "The LIFE-TB (Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea) study is a nationwide, prospective, multicenter observational cohort designed to systematically investigate the long-term impacts of tuberculosis (TB) on lung health and quality of life. This registry aims to fill the critical evidence gap in understanding post-TB lung disease (PTLD) by enrolling adults with a current diagnosis of pulmonary TB or a history of TB treatment.

Participants will be recruited from six tertiary care centers across Korea. Eligible individuals include those aged 19 or older who are either undergoing anti-TB treatment or have completed it. Exclusion criteria include extrapulmonary TB without lung involvement, age under 19, or refusal to consent.

Data will be collected at baseline and regularly over a five-year follow-up period. Clinical variables include demographic information (age, sex, BMI, smoking status), TB-related history (sputum smear/culture, drug resistance, treatment outcomes), comorbidities, and current medications. Clinical assessments involve standardized symptom scores (mMRC), chest imaging (X-ray and CT), spirometry, and validated instruments to assess quality of life (EQ-5D-5L, PROMIS, SGRQ). Laboratory data include blood tests (HbA1c, lipids), HIV/HBV/HCV status, and urine and ECG assessments at baseline.

Participants will be followed annually, with interim assessments including imaging, spirometry, and symptom scoring at specified intervals. No study-specific interventions or additional imaging are required beyond routine care. Chest CTs will only be collected if obtained for clinical purposes.

The study's primary objectives are to describe the prevalence and trajectory of PTLD-related abnormalities and identify factors associated with poor outcomes. Secondary analyses include trends in pulmonary function and quality of life over time, as well as health utilization patterns. Statistical analyses include descriptive statistics and multivariable logistic regression to identify risk factors.

All data will be anonymized and securely stored, following institutional and ethical guidelines. The study will contribute essential real-world data to inform national and international post-TB management strategies."

Eligibility criteria: Inclusion Criteria:

* Age ≥19 years
* Diagnosed with pulmonary TB and either initiating or undergoing treatment or history of treated pulmonary TB

Exclusion Criteria:

* Age \<19 years
* Extrapulmonary TB without lung involvement
* Refusal to provide informed consent

Primary outcomes:
measure: respiratory symptoms
timeFrame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
measure: abnormal radiographic findings
timeFrame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
measure: pulmonary function
timeFrame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
measure: Quality of life
timeFrame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Secondary outcomes:
measure: poor long-term outcome
timeFrame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Study officials:
References: