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Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

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ClinicalTrials.gov Identifier: NCT01269268
Recruitment Status : Unknown
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : January 4, 2011
Last Update Posted : February 5, 2014
Information provided by (Responsible Party):
Yonsei University

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
Active Tuberculosis

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Study Start Date : June 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis [ Time Frame: 6months ]

Biospecimen Retention:   Samples Without DNA
peripheral blood and serum will be retained

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
active TB patients group : from the referred center TB care clinic healthy control : from the community sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269268

Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang-Nae Cho, MD, Ph.D    82-2-2228-1819    raycho@yuhs.ac   
Contact: Young-Ae Kang, MD    82-2-2228-1986    mdkang@yuha.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01269268     History of Changes
Other Study ID Numbers: 4-2010-0213
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections