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Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01269268
First received: January 3, 2011
Last updated: February 4, 2014
Last verified: February 2014

January 3, 2011
February 4, 2014
June 2010
April 2014   (final data collection date for primary outcome measure)
Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis [ Time Frame: 6months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01269268 on ClinicalTrials.gov Archive Site
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Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

peripheral blood and serum will be retained

Non-Probability Sample

active TB patients group : from the referred center TB care clinic healthy control : from the community sample

Active Tuberculosis
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
Yes
Korea, Republic of
 
NCT01269268
4-2010-0213
No
Yonsei University
Yonsei University
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Not Provided
Yonsei University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP