Nontuberculous Mycobacterial Pulmonary DiseaseNCT04078412
A Registry for Nontuberculous Mycobacterial Pulmonary Disease
An observational study of Nontuberculous Mycobacterial Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Background: NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Pulmonary Disease
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2017to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Outpaient clinic and hospitalzed patients in tertiary referral hospital
Who may be able to join
- age 20 or more than 20 years
- diagnosed by ATS criteria for NTM pulmonary disease
Who cannot join
- 1) not specific
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
Background:
NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.
Read more
objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.
Methods:
- informed consents
- register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
- follow up 6 months to 1year based on the clinical situation
Analysis:
- treatment outcome based on NTM-NET consensus statement
- exploration of biomarker for progression and monitoring of treatment response
- Keywords
- Nontuberculous mycobacteria, pulmonary, cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NTM pulmonary disease | Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment outcome based on NTM-NET consensus statement
- For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results
- For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.
Measured: At the end of the treatment or 12months after treatment
Secondary outcomes (8)
biomarker for disease progression: RNA sequence analysis
exploration for various biomarkers with RNA sequence analysis
Measured: at the beginning of the treatment
biomarker for disease progression: metabolomic analysis
exploration for various biomarkers with metabolomic analysis
Measured: at the beginning of the treatment
biomarker for disease progression: RNA sequence analysis
exploration for various biomarkers with RNA sequence analysis
Measured: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for disease progression: metabolomic analysis
exploration for various biomarkers with metabolomic analysis
Measured: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for monitoring of treatment response: RNA sequence analysis
exploration for various biomarkers with RNA sequence analysis
Measured: at the beginning of the treatment
biomarker for monitoring of treatment response: metabolomic analysis
exploration for various biomarkers with metabolomic analysis
Measured: at the beginning of the treatment
biomarker for monitoring of treatment response: RNA sequence analysis
exploration for various biomarkers with RNA sequence analysis
Measured: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for monitoring of treatment response: metabolomic analysis
exploration for various biomarkers with metabolomic analysis
Measured: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start21 Nov 2017
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078412
- Sponsor's protocol ID
- 4-2017-0958
- Status last verified
- Nov 2019
- First submitted
- 29 Aug 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry for Nontuberculous Mycobacterial Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04078412
- Acronym / sponsor ID
- 4-2017-0958
- Keywords
- Nontuberculous mycobacteria, pulmonary, cohort
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Sep 2019 (actual)
- 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.
Background:
NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.
objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.
Methods:
- informed consents
- register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
- follow up 6 months to 1year based on the clinical situation
Analysis:
- treatment outcome based on NTM-NET consensus statement
- exploration of biomarker for progression and monitoring of treatment response
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTM pulmonary disease | – | –Cohort Description: adults NTM pulmonary disease patients diagnose by criteria of American thoracic society guideline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpaient clinic and hospitalzed patients in tertiary referral hospital
Key inclusion criteria (2 listed)
- age 20 or more than 20 years
- diagnosed by ATS criteria for NTM pulmonary disease
Key exclusion criteria (1 listed)
- 1) not specific
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
treatment outcome based on NTM-NET consensus statement
Time frame: At the end of the treatment or 12months after treatment
1. For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results 2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.
8 secondary outcomes
biomarker for disease progression: RNA sequence analysis
Time frame: at the beginning of the treatment
biomarker for disease progression: metabolomic analysis
Time frame: at the beginning of the treatment
biomarker for disease progression: RNA sequence analysis
Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for disease progression: metabolomic analysis
Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for monitoring of treatment response: RNA sequence analysis
Time frame: at the beginning of the treatment
biomarker for monitoring of treatment response: metabolomic analysis
Time frame: at the beginning of the treatment
biomarker for monitoring of treatment response: RNA sequence analysis
Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
biomarker for monitoring of treatment response: metabolomic analysis
Time frame: at the end of the treatment (through study completion, an average of 12 to 15month after treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nontuberculous Mycobacterial Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
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 2 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 2019. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
treatment outcome based on NTM-NET consensus statement (time frame: At the end of the treatment or 12months after treatment). 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 18 Nov 2019; AzTrials last refreshed its copy on 26 Oct 2026.