Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy
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Purpose
- To investigate the difference of PE inflammation/apoptosis-associated markers between TB pleurisy and non-TB pleurisy
- To investigate the difference of neutrophil apoptosis in exudative PE between TB pleurisy and non-TB pleurisy
- 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
- To investigate diagnostic aid of the inflammation/apoptosis-associated markers and apoptosis pattern of PE neutrophil for tuberculous pleurisy
| Condition |
|---|
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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 |
- diagnosis of tuberculous pleurisy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
pleural effusion
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2012 |
| Groups/Cohorts |
|---|
| 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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- Patients with tuberculous pleural effusion
- 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| Contact: Chin-Chung Shu, MD | 886-972653087 | ccshu139@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Chin-Chung Shu, MD 886972653087 ccshu139@ntu.edu.tw | |
| Principal Investigator: Chin-Chung Shu, MD | |
| Principal Investigator: | Chin-Chung Shu, MD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01685099 History of Changes |
| Other Study ID Numbers: | 201207061RIC |
| Study First Received: | September 11, 2012 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
diagnosis, inflammation-associated markers, pleural effusion, tuberculosis, tuberculous pleurisy |
Additional relevant MeSH terms:
|
Pleurisy Inflammation Tuberculosis Tuberculosis, Pleural Pathologic Processes Pleural Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013