NCT05678166 Validation of Soluble Programmed Death-1 in Predicting Progression of Nodular-bronchiectatic Form of Nontuberculous Mycobacterial Lung Disease: a Multi-Country Research
| NCT ID | NCT05678166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Nontuberculous Mycobacterial Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-01-31 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Chin-Chung Shu
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05678166 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Nontuberculous Mycobacterial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05678166 currently recruiting?
Yes, NCT05678166 is actively recruiting participants. Contact the research team at ccshu@ntu.edu.tw for enrollment information.
Where is the NCT05678166 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05678166 clinical trial?
NCT05678166 is sponsored by National Taiwan University Hospital. The principal investigator is Chin-Chung Shu at National Taiwan University Hospital. The trial plans to enroll 500 participants.