Trial record 1 of 10 for:    Open Studies | "Pleurisy"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01685099
First received: September 11, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose
  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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population
  1. Patients with tuberculous pleural effusion
  2. Patients with pleural effusion due to causes other than tuberculosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685099

Contacts
Contact: Chin-Chung Shu, MD 886-972653087 ccshu139@ntu.edu.tw

Locations
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         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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 July 23, 2014