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CompletedNCT02340897Updated Apr 20, 2016

Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

An observational study in Mycobacterium Infections, Nontuberculous, sponsored by Seoul National University Hospital. Completed. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
132
Sex
All
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Study 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 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.

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Conditions studied

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In context

Mycobacterium Infections

136 studies on the registry are indexed under Mycobacterium Infections; 17 are open to participants now.

This study's enrollment of 132 is below the median of 150 across 54 observational studies indexed under Mycobacterium Infections.

Browse Mycobacterium Infections studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
132 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

Secondary outcomes

  1. Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease

    Inter-rater correlation between four raters

    Time frame: baseline

  2. 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02340897
Lead sponsor
Seoul National University Hospital
Responsible party
Jae-Joon Yim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 19, 2015
Start date
Dec 2014
Primary completion
Feb 2015
Completion
Mar 2015
Last update
Apr 20, 2016

Study contacts

Jae-Joon Yim, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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