TuberculosisNCT00982969
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis
An observational study of Tuberculosis, run by Armed Forces Capital Hospital, Republic of Korea at 1 site in South Korea.
Trial summary
The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Apr 2010
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Soldiers in South Korean Army
Who may be able to join
- All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital
Who cannot join
- Soldiers who do not agree with study protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Armed Forces Capital Hospital
Seongnam-si, Gyeonggi-do, 463-040
About this study
Official title: The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis Among Young Adults
The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.
Read the detailed description
Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, pneumonia, QuantiFERON-TB Gold in-tube, Tuberculin skin test
- Medical subject headings
- Tuberculosis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TB suspected | Soldiers who are clinically suspected with tuberculosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionApr 2010
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Capital Hospital, Republic of Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982969
- Sponsor's protocol ID
- QFTinROKmilitary
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JE, Kim HJ, Lee SW. The clinical utility of tuberculin skin test and interferon-gamma release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study. BMC Infect Dis. 2011 Apr 18;11:96. doi: 10.1186/1471-2334-11-96.
PubMed 21501477
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis Among Young Adults
- ClinicalTrials.gov ID
- NCT00982969
- Acronym / sponsor ID
- QFTinROKmilitary
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, pneumonia, QuantiFERON-TB Gold in-tube, Tuberculin skin test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Armed Forces Capital Hospital, Republic of KoreaOther government
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Sep 2009 (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.
The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.
Detailed description
Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB suspected | – | –Soldiers who are clinically suspected with tuberculosis |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Soldiers in South Korean Army
Key inclusion criteria (1 listed)
- All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital
Key exclusion criteria (1 listed)
- Soldiers who do not agree with study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Jul 2010.
- Derived from this study: PubMed 21501477Lee JE, Kim HJ, Lee SW. The clinical utility of tuberculin skin test and interferon-gamma release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study. BMC Infect Dis. 2011 Apr 18;11:96. doi: 10.1186/1471-2334-11-96.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Armed Forces Capital Hospital, Republic of Korea 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 20 Jul 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982969, 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 20 Jul 2010.