Biomarker test using soluble PD-1 to predict progression in nodular-bronchiectatic NTM lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multi-country effort to evaluate soluble PD-1 as a biomarker for disease progression and mortality in nodular-bronchiectatic NTM lung disease. The study will measure soluble PD-1 in blood (and bronchoalveolar lavage in a subset) and correlate levels with clinical outcomes such as cavitary lesions and progression. It aims to validate prior Taiwan findings across diverse populations and ethnicities. Participants include adults with NTM-LD, sputum-positive colonizers, other NTM cases, pulmonary TB patients, and healthy controls, totaling about 500 participants. No interventional treatment is defined; the study focuses on biomarker discovery and prognostic value using observational analyses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 20 years
* NTM-LD: (N=250) Diagnosis is made on the basis of the guidelines produced by the American Thoracic Society.Patients have pulmonary symptoms with identified chest image and fit with the microbiology criteria.
* NTM pulmonary colonizers and others: (N=100) Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC or patients infected with NTM other than MAC species.
* Pulmonary tuberculosis (TB): (N=100) Those with respiratory specimen culture positive for Mycobacterium tuberculosis or typical TB pulmonary pathology.
* Healthy control (N=50)

Exclusion Criteria:

* Patients who have acquired immunodeficiency syndrome

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Chin-Chung Shu — National Taiwan University Hospital
• Study coordinator: Chin-Chung Shu
• Email: ccshu@ntu.edu.tw
• Phone: +886-2312-3456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.