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Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01269268
Collaborator
(none)
270
Enrollment
1
Location
47.4
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    270 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
    Study Start Date :
    Jun 1, 2010
    Actual Primary Completion Date :
    May 14, 2014
    Actual Study Completion Date :
    May 14, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    active tuberculosis

    active TB patients : diagnosed with TB through microbiologic examination
    healthy control

    healthy control : no evidence of respiratory disease, no respiratory symptoms, and no history of close contact of active pulmonary TB patients

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis [6months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings

    • healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients

    Exclusion Criteria:

    • pregnant woman

    • positive result of human immunodeficiency virus examination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01269268
    Other Study ID Numbers:
    • 4-2010-0213
    First Posted:
    Jan 4, 2011
    Last Update Posted:
    Mar 18, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Mar 18, 2019