TuberculosisNCT01121068
Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients
An observational study of Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Blood samplings
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care workers who are continuously exposed to TB patients
Who may be able to join
- Health care workers who are continuously exposed to TB patients Age > 20 years
Who cannot join
- Pregnant Active TB Use of immunosuppressants
Trial locations and contacts
1 site in 1 country.
South Korea1 site
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
About this study
Official title: Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients
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.
Read the detailed description
IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year.
- Conditions
- Tuberculosis
- Being tested
- Blood samplings
- Keywords
- IGRA, variability, Long-term variability of IGRA
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingsOther
About 3.5ml of blood will be drawn from the participants monthly.
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Not described Receives: Other: Blood samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of interferon-gamma releasing assay
Measured: monthly for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
- Investigators
- Jae-Joon Yim, MD, Study chair, Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121068
- Sponsor's protocol ID
- monthly IGRA
- Status last verified
- Jan 2014
- First submitted
- 9 May 2010
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22556318
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients
- ClinicalTrials.gov ID
- NCT01121068
- Acronym / sponsor ID
- monthly IGRA
- Conditions
- Tuberculosis
- Keywords
- IGRA, variability, Long-term variability of IGRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Other: Blood samplings |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers who are continuously exposed to TB patients
Key inclusion criteria (1 listed)
- Health care workers who are continuously exposed to TB patients Age > 20 years
Key exclusion criteria (1 listed)
- Pregnant Active TB Use of immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingsAbout 3.5ml of blood will be drawn from the participants monthly. | Other | Health care workers |
Primary outcome
Results of interferon-gamma releasing assay
Time frame: monthly for 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Derived from this study: PubMed 22556318Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Joon Yim, MD study chair
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of interferon-gamma releasing assay (time frame: monthly for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.