Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
This study is currently recruiting participants.
Verified June 2013 by Yonsei University
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01269268
First received: January 3, 2011
Last updated: June 1, 2013
Last verified: June 2013
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Purpose
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 |
|---|
|
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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
peripheral blood and serum will be retained
| Estimated Enrollment: | 260 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269268
Locations
| 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
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01269268 History of Changes |
| Other Study ID Numbers: | 4-2010-0213 |
| Study First Received: | January 3, 2011 |
| Last Updated: | June 1, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013