- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan University Hospital
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Chercheur principal:
- Chin-Chung Shu, MD
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Contact:
- Chin-Chung Shu, MD
- Numéro de téléphone: 886972653087
- E-mail: ccshu139@ntu.edu.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
- Patients with tuberculous pleural effusion
- Patients with pleural effusion due to causes other than tuberculosis
La description
Inclusion Criteria:
- patient older than 20 years old
- patients with exudative pleural effusion
Exclusion Criteria:
- refusal of enrollment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group with tuberculous pleurisy
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Group with non-tuberculous pleurisy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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diagnosis of tuberculous pleurisy
Délai: 2 years
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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mortalité
Délai: 2 années
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2 années
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Chin-Chung Shu, MD, National Taiwan University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Maladies pleurales
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections bactériennes à Gram positif
- Infections à Actinomycétales
- Infections à mycobactéries
- Inflammation
- Tuberculose
- Pleurésie
- Tuberculose pleurale
Autres numéros d'identification d'étude
- 201207061RIC
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