NCT01269268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2014

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

4 years

First QC Date

January 3, 2011

Last Update Submit

March 14, 2019

Conditions

Active Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis

    6months

Study Arms (2)

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 Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

active TB patients group : from the referred center TB care clinic healthy control : from the community sample

You may qualify if:

  • 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

You may not qualify if:

  • pregnant woman
  • positive result of human immunodeficiency virus examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood and serum will be retained

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

June 1, 2010

Primary Completion

May 14, 2014

Study Completion

May 14, 2014

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

KR(1)