The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01676155
First received: August 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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


Condition
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • getting active tuberculosis [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2011
Groups/Cohorts
Patient with active tuberculosis
Patients with diagnosis of latent tuberculosis infection
Patient without latent tuberculosis or active tuberculosis

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676155

Contacts
Contact: Chin-Chung Shu, MD 886-972653087 chinchungshu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chin-Chung Shu, MD    886-972653087    chinchungshu@ntu.edu.tw   
Principal Investigator: Chin-Chung Shu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01676155     History of Changes
Other Study ID Numbers: 20110822RC
Study First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Tuberculosis, latent tuberculosis infection, apoptosis, predictor

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Mycobacterium Infections
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 22, 2014