NCT01099098

Brief Summary

We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed TB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

April 4, 2010

Last Update Submit

May 11, 2011

Conditions

Tuberculosis

Keywords

People who have fibrosis or nodules in their upper lobe of the lung

Outcome Measures

Primary Outcomes (1)

  • Prevalence of latent TB infection

    At enrollment

Study Arms (2)

Patients with TB sequelae

People without TB sequelae

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with TB sequelae in their CXR

You may qualify if:

  • Age \> 20 years
  • Patients with TB sequelae in their CXR

You may not qualify if:

  • Patients on immune-suppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

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

Study Record Dates

First Submitted

April 4, 2010

First Posted

April 6, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations

KR(1)