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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
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: January 3, 2011
Last updated: February 4, 2014
Last verified: February 2014
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.

Active Tuberculosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 260
Study Start Date: June 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01269268

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

Responsible Party: Yonsei University Identifier: NCT01269268     History of Changes
Other Study ID Numbers: 4-2010-0213
Study First Received: January 3, 2011
Last Updated: February 4, 2014

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on August 22, 2017