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NCT02340897 Clinical Trial

Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

Mycobacterium Infections, Nontuberculous Clinical Trial

Official title:
Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02340897
Other study ID # 2014-1043
Secondary ID
Status Completed
Phase N/A
First received December 27, 2014
Last updated April 18, 2016
Start date December 2014
Est. completion date March 2015

Study information
Verified date April 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date March 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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 baseline No
Secondary Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease Inter-rater correlation between four raters baseline No
Secondary 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 baseline No
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