Active TuberculosisNCT01269268
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
An observational study of Active Tuberculosis, run by Yonsei University at 1 site in South Korea.
Trial summary
There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Tuberculosis
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to 14 May 2014
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: active TB patients group : from the referred center TB care clinic healthy control : from the community sample
Who may be able to join
- active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings
- healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients
Who cannot join
- pregnant woman
- positive result of human immunodeficiency virus examination
Trial locations and contacts
1 site in 1 country.
About this study
There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.
- Conditions
- Active Tuberculosis
- Medical subject headings
- Latent Tuberculosis
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 |
|---|---|---|
| active tuberculosis | active TB patients : diagnosed with TB through microbiologic examination | |
| healthy control | healthy control : no evidence of respiratory disease, no respiratory symptoms, and no history of close contact of active pulmonary TB patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJun 2010
- Primary completion14 May 2014
- Study completion14 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active TuberculosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269268
- Sponsor's protocol ID
- 4-2010-0213
- Status last verified
- Mar 2019
- First submitted
- 3 Jan 2011
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
- ClinicalTrials.gov ID
- NCT01269268
- Acronym / sponsor ID
- 4-2010-0213
- Conditions
- Active Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- 14 May 2014 (actual)
- Study completion
- 14 May 2014 (actual)
- First posted
- 4 Jan 2011 (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.
There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tuberculosis | – | –active TB patients : diagnosed with TB through microbiologic examination |
| healthy control | – | –healthy control : no evidence of respiratory disease, no respiratory symptoms, and no history of close contact of active pulmonary TB patients |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- active TB patients group : from the referred center TB care clinic healthy control : from the community sample
Key inclusion criteria (2 listed)
- active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings
- healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients
Key exclusion criteria (2 listed)
- pregnant woman
- positive result of human immunodeficiency virus examination
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
Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis
Time frame: 6months
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 18 Mar 2019.
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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 Active Tuberculosis, run by Yonsei University 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 2 inclusion and 2 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 18 Mar 2019. 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?
Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2019.