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Clinical Trials in Taiwan / NCT05678166
Recruiting Observational

Validation of Soluble Programmed Death-1 in Predicting Progression of Nodular-bronchiectatic Form of Nontuberculous Mycobacterial Lung Disease: a Multi-Country Research

NCT05678166 · tracked via the Priya Life Science Taiwan tracker
Sponsor
National Taiwan University Hospital
Phase
Observational
Started
2023-01-31
Last updated
2026-06-10

Condition(s) studied

Nontuberculous Mycobacterial Lung Disease

Study summary

The incidence of nontuberculous mycobacterial lung disease (NTM-LD) is increasing worldwide and in Eastern Asia. NTM-LD leads significant morbidity and mortality, around 25% within 5 years, but the treatment rate is low because the course of NTM-LD is indolent, especially in nodular-bronchiectatic (NB) form. However, there is no biomarker proven for predicting the progression in NB form of NTM-LD. Recently, it has been reported that the ratio of membrane-form programmed death-1 (PD-1) expressed T cells increased in patients with NTM-LD and it was associated with disease severity and progression. The mechanism has been speculated as a "immune exhaustion". In contrast to PD-1 expressed in cell membrane, soluble-form PD-1 is another biomarker that can be easily detected in serum. We recently reported that soluble PD-1 significantly correlated with cavitary lesion and disease progression in patients with NB-form NTM-LD in Taiwan. However, this has not been validated in other countries and ethnicities. Furthermore, the usefulness of soluble PD-1 in diagnosis and predicting mortality warrants further studies.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Plasma soluble PD-1 on NTM-LD diagnosis — within 2 years
  • Mortality — within 2 years
    Mortality, patient die within 2 years

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05678166 on ClinicalTrials.gov ↗ ← All trials in Taiwan