- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
-
Hovedetterforsker:
- Chin-Chung Shu, MD
-
Ta kontakt med:
- Chin-Chung Shu, MD
- Telefonnummer: 886972653087
- E-post: ccshu139@ntu.edu.tw
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- Patients with tuberculous pleural effusion
- Patients with pleural effusion due to causes other than tuberculosis
Beskrivelse
Inclusion Criteria:
- patient older than 20 years old
- patients with exudative pleural effusion
Exclusion Criteria:
- refusal of enrollment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Group with tuberculous pleurisy
|
|
Group with non-tuberculous pleurisy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
diagnosis of tuberculous pleurisy
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
dødelighet
Tidsramme: 2 år
|
2 år
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Chin-Chung Shu, MD, National Taiwan University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201207061RIC
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .