TuberculosisNCT06946784
LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea
An observational study of Tuberculosis and Post Tuberculosis, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tuberculosis, Post Tuberculosis
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2025to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB.
Who may be able to join
- Age ≥19 years
- Diagnosed with pulmonary TB and either initiating or undergoing treatment or history of treated pulmonary TB
Who cannot join
- Age <19 years
- Extrapulmonary TB without lung involvement
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul
Young Ae Kang, +82-2-2228-1986, mdkang@yuhs.ac
About this study
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.
Read the 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."
- Conditions
- Tuberculosis, Post Tuberculosis
- Keywords
- post tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active TB patients initiating or undergoing treatment or Post-treatment TB survivors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory symptoms
Prevalence and progression of respiratory symptoms (mMRC score, cough, sputum, hemoptysis)
Measured: 6month , 1year, 2year, 3year, 4year, 5year, 6year
abnormal radiographic findings
abnormal findings of chest X-ray or chest CT
Measured: 6month , 1year, 2year, 3year, 4year, 5year, 6year
pulmonary function
Pulmonary function measured by spirometry: FEV1, FVC, FEV1/FVC
Measured: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Quality of life
Quality of life measured by EQ-5D-5L, PROMIS, SGRQ
Measured: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Secondary outcomes (1)
poor long-term outcome
Association of poor long-term outcomes with demographic and clinical variables (age, sex, BMI, comorbidities)
Measured: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946784
- Sponsor's protocol ID
- 4-2024-1620
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41088970
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE-TB ; Long-Term Impacts on Lung Health and Life After Tuberculosis in Korea
- ClinicalTrials.gov ID
- NCT06946784
- Acronym / sponsor ID
- 4-2024-1620
- Conditions
- Tuberculosis, Post Tuberculosis
- Keywords
- post tuberculosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active TB patients initiating or undergoing treatment or Post-treatment TB survivors | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB.
Key inclusion criteria (2 listed)
- Age ≥19 years
- Diagnosed with pulmonary TB and either initiating or undergoing treatment or history of treated pulmonary TB
Key exclusion criteria (3 listed)
- Age <19 years
- Extrapulmonary TB without lung involvement
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
respiratory symptoms
Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Prevalence and progression of respiratory symptoms (mMRC score, cough, sputum, hemoptysis)
abnormal radiographic findings
Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
abnormal findings of chest X-ray or chest CT
pulmonary function
Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Pulmonary function measured by spirometry: FEV1, FVC, FEV1/FVC
Quality of life
Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Quality of life measured by EQ-5D-5L, PROMIS, SGRQ
1 secondary outcome
poor long-term outcome
Time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 41088970Chung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Post Tuberculosis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory symptoms (time frame: 6month , 1year, 2year, 3year, 4year, 5year, 6year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.