Mycobacterium Infections, NontuberculousNCT02340897
Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT
An observational study of Mycobacterium Infections, Nontuberculous, run by Seoul National University Hospital.
Trial summary
The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycobacterium Infections, Nontuberculous
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis
Who may be able to join
- Nontuberculous mycobacterial patients satisfying diagnostic criteria suggested by American Thoracic Society
- Patients with bacteriologically confirmed pulmonary tuberculosis
- Patients with bronchiectasis, confirmed by clinically as well as radiographically
Who cannot join
- None
About this study
Official title: Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease
The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.
Read the detailed description
To elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest CT, two pulmonologists and two chest radiologists were requested to interpret chest CT of patients nontuberculous mycobacterial lung disease satisfying diagnostic criteria of American Thoracic Society as well as British Thoracic Society, or pulmonary tuberculosis. Two pulmonologists and two chest radiologists > 10 years of clinical experiences at a tertiary referral hospital participated as raters in this study. They were blinded to the any clinical information of the patients including the specific diagnosis, except age and sex. The interpretations of four raters were analyzed and compared.
- Conditions
- Mycobacterium Infections, Nontuberculous
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
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 |
|---|---|---|
| Nontuberculous lung disease | Patients with Nontuberculous Mycobacteria satisfying American Thoracic Society and British Thoracic Society guidelines | |
| pulmonary tuberculosis | Patients with culture confirmed tuberculosis | |
| bronchiectasis | Patients with bronchiectasis based on chest CT findings as well as symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease
Percentage of cases diagnosed as nontuberculous mycobacterial lung disease by four raters out of confirmed cases with nontuberculous mycobacterial lung disease
Measured: baseline
Secondary outcomes (2)
Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease
Inter-rater correlation between four raters
Measured: baseline
Specificity for the diagnosis nontuberculous mycobacterial lung disease
Percentage of cases diagnosed as other than nontuberculous mycobacterial lung disease by four raters out of confirmed cases with other than nontuberculous mycobacterial lung disease
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Infections, NontuberculousStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
- Investigators
- Jae-Joon Yim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340897
- Sponsor's protocol ID
- 2014-1043
- Status last verified
- Apr 2016
- First submitted
- 27 Dec 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease
- ClinicalTrials.gov ID
- NCT02340897
- Acronym / sponsor ID
- 2014-1043
- Conditions
- Mycobacterium Infections, Nontuberculous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jan 2015 (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.
The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.
Detailed description
To elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest CT, two pulmonologists and two chest radiologists were requested to interpret chest CT of patients nontuberculous mycobacterial lung disease satisfying diagnostic criteria of American Thoracic Society as well as British Thoracic Society, or pulmonary tuberculosis. Two pulmonologists and two chest radiologists > 10 years of clinical experiences at a tertiary referral hospital participated as raters in this study. They were blinded to the any clinical information of the patients including the specific diagnosis, except age and sex. The interpretations of four raters were analyzed and compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nontuberculous lung disease | – | –Patients with Nontuberculous Mycobacteria satisfying American Thoracic Society and British Thoracic Society guidelines |
| pulmonary tuberculosis | – | –Patients with culture confirmed tuberculosis |
| bronchiectasis | – | –Patients with bronchiectasis based on chest CT findings as well as symptoms |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis
Key inclusion criteria (3 listed)
- Nontuberculous mycobacterial patients satisfying diagnostic criteria suggested by American Thoracic Society
- Patients with bacteriologically confirmed pulmonary tuberculosis
- Patients with bronchiectasis, confirmed by clinically as well as radiographically
Key exclusion criteria (1 listed)
- None
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
Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease
Time frame: baseline
Percentage of cases diagnosed as nontuberculous mycobacterial lung disease by four raters out of confirmed cases with nontuberculous mycobacterial lung disease
2 secondary outcomes
Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease
Time frame: baseline
Specificity for the diagnosis nontuberculous mycobacterial lung disease
Time frame: baseline
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 20 Apr 2016.
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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.
Jae-Joon Yim, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Infections, Nontuberculous, run by Seoul National University Hospital.
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 3 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease (time frame: baseline). 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 20 Apr 2016.