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The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis

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ClinicalTrials.gov Identifier: NCT01676155
Recruitment Status : Unknown
Verified June 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date August 28, 2012
First Posted Date August 30, 2012
Last Update Posted Date August 30, 2012
Study Start Date September 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 28, 2012)
getting active tuberculosis [ Time Frame: 2 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 28, 2012)
mortality [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis
Official Title The Role of Apoptosis Associated Markers in Pathogenesis of Pulmonary Tuberculosis
Brief 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
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
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
Intervention Not Provided
Study Groups/Cohorts
  • Patient with active tuberculosis
  • Patients with diagnosis of latent tuberculosis infection
  • Patient without latent tuberculosis or active tuberculosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 28, 2012)
400
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01676155
Other Study ID Numbers 20110822RC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2012