To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBINCT01676155
The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis
An observational study of To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI and To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBI, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To compare the serum apoptosis-associated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI, To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBI
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2011to not given
- 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: 1. Patients with tuberculosis: microbiology or pathology proven tuberculosis infection 2. Patients with latent tuberculosis infection are defined by interferon-gamma release assay 3. Patients without tuberculosis and latent tuberculosis are defi=ed by negative findings in above-mentioned results
Who may be able to join
- Age ≥ 20 years
- Latent TB group: family contacts who have positive response in IGRA (by QuantiFeron-TB Gold-in-Tube, which is described detail in Part C) and have no signs of active TB.
- Active TB group: patients with pulmonary tuberculosis diagnosed by positive respiratory culture.
Who cannot join
- Age younger than 20 years.
- Patients who have pregnancy.
- Patients who have acquired immunodeficiency syndrome
- Patients who have bleeding tendency which can not tolerate venous puncture such as hemophilia, thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chin-Chung Shu, MD, 886-972653087, chinchungshu@ntu.edu.tw
Chin-Chung Shu, MD
About this study
To compare the serum apoptosis-associated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI
Read the detailed description
Background: Tuberculosis (TB) remains the most important infectious disease worldwide. For controlling TB, the important strategy includes not only adequate anti-tuberculous treatment but also well control of latent TB infection (LTBI). Latent TB infection (LTBI) has 10% of reactivation or more in patients with immuno-compromised disorder. Although LTBI can be detected by interferon-gamma release assay (IGRA) or tuberculin skin test, how to predict who will become active TB from LTBI is still unclear but important. In overall prophylactic treatment for LTBI, the lengthy duration and possible serious side effect too scared to general application especially 90% of population who may not get illness. Therefore, to recognize who develop active TB from LTBI is important for targeted prophylactic therapy. The good marker is not discovered at present. When TB bacilli arrive our lung, macrohage is the first line defense and necrosis rather than apoptosis is the dominant form of cell death, which affords a protective milieu for M. tuberculosis. Though the apoptosis is suppressed in TB, the apoptosis-associated markers have rarely been investigated in human LTBI vs. active TB. We set up a cohort study to detect active TB developing from LTBI and first-step conduct a case control study to compare apoptosis markers between LTBI and active TB for evaluating the apoptosis markers in discriminating TB infection status. The significant markers should be verified in further cohort study of LTBI patients.
Hypothesis: The apoptosis-associated markers, including Fas ligand, Decoy-receptor 3, Lipoxin, and prostaglandin E2, are discriminative in patients with active TB from those with LTBI and thus might predict the potential of being active TB from LTBI.
Study Aims:
To compare the serum apoptosis-associated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI Methods: We prospectively enroll patients with active TB (n=100) and LTBI (n=100), defined by IGRA. Blood sample would be collected before they received definite treatment after yielding informed consent. We will examine serum apoptosis-associated markers including Fas ligand, Decoy-receptor 3, Lipoxin, and prostaglandin E2, and other cytokines and chemokines in serum sample and supernatant from T-cell after TB antigen stimulation. Their clinical characteristics will be recorded. We compare the laboratory and clinical data between the two groups and analyze the efficacy of diagnostic help from these markers.
- Conditions
- To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI, To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBI
- Keywords
- Tuberculosis, latent tuberculosis infection, apoptosis, predictor
- Medical subject headings
- Tuberculosis, 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 |
|---|---|---|
| Patient with active tuberculosis | Not described | |
| Patients with diagnosis of latent tuberculosis infection | Not described | |
| Patient without latent tuberculosis or active tuberculosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
getting active tuberculosis
Measured: 2 year
Secondary outcomes (1)
mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBIStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676155
- Sponsor's protocol ID
- 20110822RC
- Status last verified
- Jun 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT01676155
- Acronym / sponsor ID
- 20110822RC
- Conditions
- To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI, To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBI
- Keywords
- Tuberculosis, latent tuberculosis infection, apoptosis, predictor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- First posted
- 30 Aug 2012 (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.
To compare the serum apoptosis-associated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI
Detailed description
Background: Tuberculosis (TB) remains the most important infectious disease worldwide. For controlling TB, the important strategy includes not only adequate anti-tuberculous treatment but also well control of latent TB infection (LTBI). Latent TB infection (LTBI) has 10% of reactivation or more in patients with immuno-compromised disorder. Although LTBI can be detected by interferon-gamma release assay (IGRA) or tuberculin skin test, how to predict who will become active TB from LTBI is still unclear but important. In overall prophylactic treatment for LTBI, the lengthy duration and possible serious side effect too scared to general application especially 90% of population who may not get illness. Therefore, to recognize who develop active TB from LTBI is important for targeted prophylactic therapy. The good marker is not discovered at present. When TB bacilli arrive our lung, macrohage is the first line defense and necrosis rather than apoptosis is the dominant form of cell death, which affords a protective milieu for M. tuberculosis. Though the apoptosis is suppressed in TB, the apoptosis-associated markers have rarely been investigated in human LTBI vs. active TB. We set up a cohort study to detect active TB developing from LTBI and first-step conduct a case control study to compare apoptosis markers between LTBI and active TB for evaluating the apoptosis markers in discriminating TB infection status. The significant markers should be verified in further cohort study of LTBI patients.
Hypothesis: The apoptosis-associated markers, including Fas ligand, Decoy-receptor 3, Lipoxin, and prostaglandin E2, are discriminative in patients with active TB from those with LTBI and thus might predict the potential of being active TB from LTBI.
Study Aims:
To compare the serum apoptosis-associated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI Methods: We prospectively enroll patients with active TB (n=100) and LTBI (n=100), defined by IGRA. Blood sample would be collected before they received definite treatment after yielding informed consent. We will examine serum apoptosis-associated markers including Fas ligand, Decoy-receptor 3, Lipoxin, and prostaglandin E2, and other cytokines and chemokines in serum sample and supernatant from T-cell after TB antigen stimulation. Their clinical characteristics will be recorded. We compare the laboratory and clinical data between the two groups and analyze the efficacy of diagnostic help from these markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with active tuberculosis | – | – |
| Patients with diagnosis of latent tuberculosis infection | – | – |
| Patient without latent tuberculosis or active tuberculosis | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with tuberculosis: microbiology or pathology proven tuberculosis infection 2. Patients with latent tuberculosis infection are defined by interferon-gamma release assay 3. Patients without tuberculosis and latent tuberculosis are defi=ed by negative findings in above-mentioned results
Key inclusion criteria (3 listed)
- Age ≥ 20 years
- Latent TB group: family contacts who have positive response in IGRA (by QuantiFeron-TB Gold-in-Tube, which is described detail in Part C) and have no signs of active TB.
- Active TB group: patients with pulmonary tuberculosis diagnosed by positive respiratory culture.
Key exclusion criteria (4 listed)
- Age younger than 20 years.
- Patients who have pregnancy.
- Patients who have acquired immunodeficiency syndrome
- Patients who have bleeding tendency which can not tolerate venous puncture such as hemophilia, thrombocytopenia.
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
getting active tuberculosis
Time frame: 2 year
1 secondary outcome
mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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.
Chin-Chung Shu, MD principal investigator
National Taiwan University Hospital
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 To Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI and To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBI, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Chung Shu, MD (886-972653087, chinchungshu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
getting active tuberculosis (time frame: 2 year). 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 30 Aug 2012.