NCT01121068

Brief Summary

Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis. However,IGRA responses could show within-subject variability. We wanted to determine long-term IGRA variability in health-care workers who continuously expose to tuberculosis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

May 9, 2010

Last Update Submit

January 3, 2014

Conditions

Tuberculosis

Keywords

IGRAvariabilityLong-term variability of IGRA

Outcome Measures

Primary Outcomes (1)

  • Results of interferon-gamma releasing assay

    monthly for 1 year

Study Arms (1)

Health care workers

Other: Blood samplings

Interventions

Blood samplingsOTHER

About 3.5ml of blood will be drawn from the participants monthly.

Health care workers

Eligibility Criteria

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

Health care workers who are continuously exposed to TB patients

You may qualify if:

  • Health care workers who are continuously exposed to TB patients Age \> 20 years

You may not qualify if:

  • Pregnant Active TB Use of immunosuppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Park JS, Lee JS, Kim MY, Lee CH, Yoon HI, Lee SM, Yoo CG, Kim YW, Han SK, Yim JJ. Monthly follow-ups of interferon-gamma release assays among health-care workers in contact with patients with TB. Chest. 2012 Dec;142(6):1461-1468. doi: 10.1378/chest.11-3299.

    PMID: 22556318DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisParacentesisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jae-Joon Yim, MD

    Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

KR(1)