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Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269268
First Posted: January 4, 2011
Last Update Posted: February 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
January 3, 2011
January 4, 2011
February 5, 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 ]
Not Provided
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.
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01269268
4-2010-0213
No
Not Provided
Not Provided
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
February 2014