NCT06946784

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2025Dec 2031

Study Start

First participant enrolled

February 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

April 13, 2025

Last Update Submit

April 20, 2025

Conditions

Keywords

post tuberculosis

Outcome Measures

Primary Outcomes (4)

  • respiratory symptoms

    Prevalence and progression of respiratory symptoms (mMRC score, cough, sputum, hemoptysis)

    6month , 1year, 2year, 3year, 4year, 5year, 6year

  • abnormal radiographic findings

    abnormal findings of chest X-ray or chest CT

    6month , 1year, 2year, 3year, 4year, 5year, 6year

  • pulmonary function

    Pulmonary function measured by spirometry: FEV1, FVC, FEV1/FVC

    6month , 1year, 2year, 3year, 4year, 5year, 6year

  • Quality of life

    Quality of life measured by EQ-5D-5L, PROMIS, SGRQ

    6month , 1year, 2year, 3year, 4year, 5year, 6year

Secondary Outcomes (1)

  • poor long-term outcome

    6month , 1year, 2year, 3year, 4year, 5year, 6year

Study Arms (1)

Active TB patients initiating or undergoing treatment or Post-treatment TB survivors

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants either undergoing treatment for pulmonary tuberculosis or with a history of treated TB.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 27, 2025

Study Start

February 25, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations