Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01269268
First received: January 3, 2011
Last updated: February 4, 2014
Last verified: February 2014
  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: April 2014
Estimated Primary Completion Date: April 2014 (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
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 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: February 4, 2014
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 August 28, 2014