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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01685099
• Other study ID #: 201207061RIC
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2012
• Last updated: September 11, 2012
• Start date: August 2012

Study information

• Verified date: August 2012
• Source: National Taiwan University Hospital
• Contact: Chin-Chung Shu, MD
• Phone: 886-972653087
• Email: ccshu139[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patient older than 20 years old

• patients with exudative pleural effusion

Exclusion Criteria:

• refusal of enrollment

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of tuberculous pleurisy		2 years	No
Secondary	mortality		2 years	No