Menu
Recruiting NCT06946784

LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea

Observational Tuberculosis Post Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tuberculosis, Post Tuberculosis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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."

Primary outcome measures

  • respiratory symptoms [Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year]
  • abnormal radiographic findings [Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year]
  • pulmonary function [Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year]
  • Quality of life [Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year]
Secondary outcome measures (1)
  • poor long-term outcome [Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmono — Seoul

Publications

  • Chung C, Min J, Jeon D, Kwon YS, Mok J, Kim HW, Park Y, Kang YA. Protocol of a Nationwide Observational Cohort Study for Long-Term Impacts on Lung Health and Life after Tuberculosis in Korea (LIFE-TB). Tuberc Respir Dis (Seoul). 2026 Jan;89(1):86-93. doi: 10.4046/trd.2025.0109. Epub 2025 Oct 15. PMID 41088970

Identifiers

NCT: NCT06946784 · 4-2024-1620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗