NCT02340897

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

December 27, 2014

Last Update Submit

April 18, 2016

Conditions

Mycobacterium Infections, Nontuberculous

Outcome Measures

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

    baseline

Secondary Outcomes (2)

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

    baseline

  • Specificity for the diagnosis nontuberculous mycobacterial lung disease

    baseline

Study Arms (3)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Jae-Joon Yim, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2014

First Posted

January 19, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04