Mycobacterium AviumNCT02779049
Program Cell Death Receptor 1 in Mycobacterium Avium Complex Lung Disease
An observational study of Mycobacterium Avium, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Avium
- What is being tested?
- Blood examination
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with Mycobacterium avium complex lung disease
Who may be able to join
- Age ≥ 20 years
- MAC lung disease: Diagnosis is based on the guidelines by American Thoracic Society. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria.
- 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
Who cannot join
- Patients who have acquired immunodeficiency syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pathogenic Role and Diagnostic Implication of Program Cell Death Receptor 1 Expressed on T Cells in Mycobacterium Avium Complex Lung Disease
- To understand the components of PBMC in MAC-LD patients, including T cells, B cells, nature killer cells, and monocyte.
- To confirm the phenomenon of reduced PBMC response in MAC-LD patients
- 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.
- 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,
- To examine the PD-1 gene polymorphism and the correlation with MAC-LD.
Read the detailed description
Background: Nontuberculous mycobacteria Lung disease (NTM-LD) becomes an important clinical concern, because its incidence has increased over the last decade. Mycobacterium avium complex (MAC) is the most common responsible species for NTM-LD in Taiwan. The clinical relevance of MAC in sputum is, however, only 35~42% because it exists in the environment ubiquitously. According to the guideline of the American Thoracic Society, the diagnosis of MAC-LD is based on clinical, radiographic, and mycobacteriology criteria which require two or more positive sputum cultures for MAC. The major limitation of mycobacterial culture is the long turn-around-time, usually 2-4 weeks. In addition, both mycobacterial culture and nucleic acid amplification test cannot discriminate true MAC infection and colonization because airway colonization of MAC is not uncommon. Therefore, diagnosis of MAC-LD remains a big challenge in clinical practice, and rapid and accurate diagnostic test should be developed.
Beyond the contemporary diagnostic criteria, the host immune response in NTM disease has recently been proposed to help diagnosis. Inflammatory markers may represent host response and discriminate MAC infection from colonization. But inflammatory markers can be influenced by infection other than MAC infection. By contrast, lymphocyte response to antigen stimulation may be more specific in diagnosis. In our preliminary results, in-vitro response of peripheral blood mononuclear cell (PBMC) is lower in MAC-LD than healthy controls. The underlying mechanism responsible for the reduced PBMC response in MAC-LD is not fully understood. In previous studies conducted in tuberculosis patients, interaction between programmed cell death ligand-1 (PD-L1) from dendritic cells and programmed cell death-1 (PD-1) in T cells leads to apoptosis or anergy of T lymphocyte and thus suppresses cellular immunity. Therefore, it is possible that similar alteration in immune response also occurs in patients with MAC-LD and correlates with the PBMC response as well as disease severity.
- Conditions
- Mycobacterium Avium
- Being tested
- Blood examination
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood examinationOther
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| MAC-LD | patients with MAC-LD Do Blood examination Receives: Other: Blood examination | |
| Control | controls without NTM or tuberculosis infection Do Blood examination Receives: Other: Blood examination | |
| Tuberculosis infection | patients with tuberculosis infection which diagnosis by culture or typical pathology Do Blood examination Receives: Other: Blood examination | |
| MAC colonization | patients with MAC pulmonary colonization by American Thoracic Society guideline Do Blood examination Receives: Other: Blood examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of disease progression
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium AviumStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779049
- Sponsor's protocol ID
- 201407079RIND
- Status last verified
- Dec 2016
- First submitted
- 18 May 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenic Role and Diagnostic Implication of Program Cell Death Receptor 1 Expressed on T Cells in Mycobacterium Avium Complex Lung Disease
- ClinicalTrials.gov ID
- NCT02779049
- Acronym / sponsor ID
- 201407079RIND
- Conditions
- Mycobacterium Avium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To understand the components of PBMC in MAC-LD patients, including T cells, B cells, nature killer cells, and monocyte.
- To confirm the phenomenon of reduced PBMC response in MAC-LD patients
- 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.
- 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,
- To examine the PD-1 gene polymorphism and the correlation with MAC-LD.
Detailed description
Background: Nontuberculous mycobacteria Lung disease (NTM-LD) becomes an important clinical concern, because its incidence has increased over the last decade. Mycobacterium avium complex (MAC) is the most common responsible species for NTM-LD in Taiwan. The clinical relevance of MAC in sputum is, however, only 35~42% because it exists in the environment ubiquitously. According to the guideline of the American Thoracic Society, the diagnosis of MAC-LD is based on clinical, radiographic, and mycobacteriology criteria which require two or more positive sputum cultures for MAC. The major limitation of mycobacterial culture is the long turn-around-time, usually 2-4 weeks. In addition, both mycobacterial culture and nucleic acid amplification test cannot discriminate true MAC infection and colonization because airway colonization of MAC is not uncommon. Therefore, diagnosis of MAC-LD remains a big challenge in clinical practice, and rapid and accurate diagnostic test should be developed.
Beyond the contemporary diagnostic criteria, the host immune response in NTM disease has recently been proposed to help diagnosis. Inflammatory markers may represent host response and discriminate MAC infection from colonization. But inflammatory markers can be influenced by infection other than MAC infection. By contrast, lymphocyte response to antigen stimulation may be more specific in diagnosis. In our preliminary results, in-vitro response of peripheral blood mononuclear cell (PBMC) is lower in MAC-LD than healthy controls. The underlying mechanism responsible for the reduced PBMC response in MAC-LD is not fully understood. In previous studies conducted in tuberculosis patients, interaction between programmed cell death ligand-1 (PD-L1) from dendritic cells and programmed cell death-1 (PD-1) in T cells leads to apoptosis or anergy of T lymphocyte and thus suppresses cellular immunity. Therefore, it is possible that similar alteration in immune response also occurs in patients with MAC-LD and correlates with the PBMC response as well as disease severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAC-LD | – | Other: Blood examinationpatients with MAC-LD Do Blood examination |
| Control | – | Other: Blood examinationcontrols without NTM or tuberculosis infection Do Blood examination |
| Tuberculosis infection | – | Other: Blood examinationpatients with tuberculosis infection which diagnosis by culture or typical pathology Do Blood examination |
| MAC colonization | – | Other: Blood examinationpatients with MAC pulmonary colonization by American Thoracic Society guideline Do Blood examination |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Mycobacterium avium complex lung disease
Key inclusion criteria (5 listed)
- Age ≥ 20 years
- MAC lung disease: Diagnosis is based on the guidelines by American Thoracic Society. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria.
- 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
Key exclusion criteria (1 listed)
- Patients who have acquired immunodeficiency syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood examinationblood sampling | Other | Control, MAC colonization, MAC-LD, Tuberculosis infection |
Primary outcome
Percent of disease progression
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Mycobacterium Avium
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Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Chung Shu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Avium, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of disease progression (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.