- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01685099
Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy
- 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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
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Huvudutredare:
- Chin-Chung Shu, MD
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Kontakt:
- Chin-Chung Shu, MD
- Telefonnummer: 886972653087
- E-post: ccshu139@ntu.edu.tw
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
- Patients with tuberculous pleural effusion
- Patients with pleural effusion due to causes other than tuberculosis
Beskrivning
Inclusion Criteria:
- patient older than 20 years old
- patients with exudative pleural effusion
Exclusion Criteria:
- refusal of enrollment
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Group with tuberculous pleurisy
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Group with non-tuberculous pleurisy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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diagnosis of tuberculous pleurisy
Tidsram: 2 years
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2 years
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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dödlighet
Tidsram: 2 år
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2 år
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Chin-Chung Shu, MD, National Taiwan University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201207061RIC
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