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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: September 11, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

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

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
pleural effusion

Estimated Enrollment: 200
Study Start Date: August 2012
Group with tuberculous pleurisy
Group with non-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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01685099

Contact: Chin-Chung Shu, MD 886-972653087

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
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital Identifier: NCT01685099     History of Changes
Other Study ID Numbers: 201207061RIC
Study First Received: September 11, 2012
Last Updated: September 11, 2012

Keywords provided by National Taiwan University Hospital:
diagnosis, inflammation-associated markers, pleural effusion, tuberculosis, tuberculous pleurisy

Additional relevant MeSH terms:
Tuberculosis, Pleural
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on August 16, 2017