Program Cell Death Receptor 1 in Mycobacterium Avium Complex Lung Disease
The Pathogenic Role and Diagnostic Implication of Program Cell Death Receptor 1 Expressed on T Cells in Mycobacterium Avium Complex Lung Disease
1 other identifier
observational
112
1 country
1
Brief Summary
- 1.To understand the components of PBMC in MAC-LD patients, including T cells, B cells, nature killer cells, and monocyte.
- 2.To confirm the phenomenon of reduced PBMC response in MAC-LD patients
- 3.To study the proportion of apoptosis and PD-1 expression in T cells among MAC-LD patients, MAC colonizers, patients with tuberculosis, and healthy controls.
- 4.To study the apoptosis and PD-1/PD-L1 expression in T cells/macrophage from bronchial lavage among MAC-LD patients, MAC colonizers, patients with tuberculosis,
- 5.To examine the PD-1 gene polymorphism and the correlation with MAC-LD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 15, 2016
December 1, 2016
1.5 years
May 18, 2016
December 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of disease progression
2 year
Study Arms (4)
MAC-LD
patients with MAC-LD Do Blood examination
Control
controls without NTM or tuberculosis infection Do Blood examination
Tuberculosis infection
patients with tuberculosis infection which diagnosis by culture or typical pathology Do Blood examination
MAC colonization
patients with MAC pulmonary colonization by American Thoracic Society guideline Do Blood examination
Interventions
Eligibility Criteria
Patient with Mycobacterium avium complex lung disease
You may qualify if:
- Age ≥ 20 years
- MAC pulmonary colonizers: Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC are defined.
- Healthy controls:
- Active tuberculosis group: patients with pulmonary tuberculosis diagnosed by positive respiratory culture
You may not qualify if:
- Patients who have acquired immunodeficiency syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Chung Shu, MD
National Taiwan University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 20, 2016
Study Start
January 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
December 15, 2016
Record last verified: 2016-12