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

NCT05678166 | Unknown

• 1 other identifier: 202210007RINC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Nontuberculous Mycobacterial Lung Disease

Outcome Measures

Primary Outcomes (2)

• Plasma soluble PD-1 on NTM-LD diagnosis

  within 2 years

• Mortality

  Mortality, patient die within 2 years

  within 2 years

Study Arms (4)

NTM-LD

Diagnosis is made on the basis of the guidelines produced by the American Thoracic Society . Briefly, Patients have pulmonary symptoms with identified chest image and fit with the microbiology criteria.

NTM pulmonary colonizers and others

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)

Those with respiratory specimen culture positive for Mycobacterium tuberculosis or typical TB pulmonary pathology.

Healthy control

Healthy control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NTM-LD at National University Hospital, Taiwan ,Fukujuji Hospital, Japan and Seoul National University, Korea.

You may qualify if:

• 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)

You may not qualify if:

• Patients who have acquired immunodeficiency syndrome

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Chin-Chung Shu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Chung Shu

CONTACT

+886-2312-3456; ccshu@ntu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: January 31, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 31, 2024
• Last Updated: January 19, 2023

Record last verified: 2022-09

Locations

TW (1)