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Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685099
Recruitment Status : Unknown
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 13, 2012
Last Update Posted : September 13, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
  1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB pleurisy and non-TB pleurisy
  2. To investigate the difference of neutrophil apoptosis in exudative PE between TB pleurisy and non-TB pleurisy
  3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy
  4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and apoptosis pattern of PE neutrophil for tuberculous pleurisy

Condition or disease
To Investigate Diagnostic Aid of the Inflammation and Apoptosis-associated Markers and Apoptosis Pattern of PE Neutrophil for Tuberculous Pleurisy

Detailed Description:

Tuberculosis (TB) remains a global health problem even though it has nearly been eradicated in some developed countries. Because of variable manifestations and the difficulty in collecting clinical samples, extra-pulmonary TB is usually difficult to early diagnose. Tuberculous pleurisy (TP) is one of the most common extra-pulmonary infection and accounts for approximately 5% of all forms of TB. The gold standard for diagnosing TP is mycobacterial culture of pleural effusion (PE), pleura tissue, which requires weeks to yield. The treatment could thus be delayed, resulting in an increased mortality rate. In addition, mycobacterial culture is not so sensitive for PE and with positivity in less than two thirds of cases with TB pleurisy.

For diagnosing TP, PE biomarkers are required to be investigated in addition to traditional PE cell counting and biochemistry. In particularly, inflammation-associated cytokines and apoptosis-associated markers may be important because the two pathways involve in TB infection/defense mechanism. For inflammation-association markers, current literature is not comprehensive except IFN-gamma and IFN-gamma release assay (IGRA). However, the result of IGRA using PE is disappointed. We should study other PE inflammation markers such as IFN-induced protein-10, interleukin [IL]-2, IL-12 and so on. On the other hand, apoptosis suppression is one of escape mechanisms in TB pathogenesis. Macrophage, dendritic cell, and neutrophil are reportedly inhibited for apoptosis in TB infection. But the apoptosis of PE neutrophil are rarely studied. Moreover, the role of apoptosis-associated markers (Fas ligand [FasL], decoy receptor 3, lipoxin, prostaglandin E2, caspases) in PE has rarely been investigated in diagnosing TP except FasL. Therefore, we conduct a prospective study to investigate inflammation/apoptosis-associated markers in exudative PE and apoptosis of PE neutrophil to analyze their diagnostic usefulness for TP.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy
Study Start Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group with tuberculous pleurisy
Group with non-tuberculous pleurisy

Primary Outcome Measures :
  1. diagnosis of tuberculous pleurisy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
pleural effusion

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with tuberculous pleural effusion
  2. Patients with pleural effusion due to causes other than tuberculosis

Inclusion Criteria:

  • patient older than 20 years old
  • patients with exudative pleural effusion

Exclusion Criteria:

  • refusal of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685099

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Contact: Chin-Chung Shu, MD 886-972653087

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chin-Chung Shu, MD    886972653087   
Principal Investigator: Chin-Chung Shu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital Identifier: NCT01685099    
Other Study ID Numbers: 201207061RIC
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: August 2012
Keywords provided by National Taiwan University Hospital:
diagnosis, inflammation-associated markers, pleural effusion, tuberculosis, tuberculous pleurisy
Additional relevant MeSH terms:
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Tuberculosis, Pleural
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections