Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

This study is currently recruiting participants.

Verified August 2011 by Yonsei University

Sponsor:

Information provided by:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01269268

First received: January 3, 2011

Last updated: August 15, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 3, 2011
Last Updated Date	August 15, 2011
Start Date ^ICMJE	June 2010
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01269268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Official Title ^ICMJE	Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: peripheral blood and serum will be retained
Sampling Method	Non-Probability Sample
Study Population	active TB patients group : from the referred center TB care clinic healthy control : from the community sample
Condition ^ICMJE	Active Tuberculosis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	260
Estimated Completion Date	February 2014
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01269268
Other Study ID Numbers ^ICMJE	4-2010-0213
Has Data Monitoring Committee	No
Responsible Party	Sang-Nae Cho / Professor, Severance Hospital, Department of Microbiology, YUHS
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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