- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850043
The Epidemiology of TST Change in Korea
December 11, 2013 updated by: Sei Won Lee, Asan Medical Center
The Trend of Tuberculin Skin Test in Korea
TST will be analyzed in young general population in Korea.
Young adults undertake TST as CDC recommendation.
Participants with chest radiograph showing active TB lesion are excluded from this study.
Study Overview
Status
Completed
Conditions
Detailed Description
Enroll criteria
- A term of whole military conscripts per year in one Reserve Force Battalion
- Military conscripts gather from all around area in Korea randomly
- Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.
Exclusion Criteria
- Chest X-ray suggesting active TB
- HIV positive in serology
Design
- After giving informed consent, all participants receive one-step TST following standard procedures.
- The largest transverse diameter of induration is measured 48-72hr after injection.
- The investigator and these trained nurses were blinded to the status of their demographic characteristics.
Study Type
Observational
Enrollment (Actual)
5552
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chungcheongbuk-Do
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Osong, Chungcheongbuk-Do, Korea, Republic of, 396-954
- The Korean Institute of Tuberculosis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
A term of whole military conscripts per year
Description
Inclusion Criteria:
- Military Conscripts age 18-29 years old
Exclusion Criteria:
- Chest X-ray suggests active TB
- Positive HIV in serology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Military Conscripts
A term of whole military conscripts per year in one Reserve Force Battalion.
Military conscripts gather from all around area in Korea randomly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TST positivity TST rate
Time Frame: Two days after tuberculin injection
|
Investigators measure induration size of tuberculin skin test 48 after tuberculin injection.
|
Two days after tuberculin injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BCG scar rates
Time Frame: The day of tuberculin injection
|
The day of tuberculin injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: HeeJin Kim, MD, The Korean Institute of Tuberculosis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 2, 2013
First Submitted That Met QC Criteria
May 7, 2013
First Posted (Estimate)
May 9, 2013
Study Record Updates
Last Update Posted (Estimate)
December 12, 2013
Last Update Submitted That Met QC Criteria
December 11, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KoreanTSTtrends
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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