- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01454856
Perioperative Evaluation of Immuno-inflammatory Parameters
This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.
This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
A significant number of published data can be concluded that surgery and anesthetic and analgesic techniques have an impact on immunity and inflammation.
However, none of these studies have been performed with modern techniques, much more reliable evaluation of immune activity, such as the assessment of monocytic degranulation by flow cytometry.
It is therefore important to document immune activity using these new techniques, our patients, perioperative. This will be analyzed, so observational, the potential impact of different therapeutic interventions the patient receives.
This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected.
This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Brussels, Belgien, 1200
- Cliniques Universitaires Saint-luc
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Surgical patients (and controls)
Exclusion Criteria:
- Immune disorders
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Surgical cancer patients
No modification of the treatment
|
|
Non-surgical cancer patients
No modification of the treatment
|
|
Surgical non-cancer patients
No modification of the treatment
|
|
Non-surgical non-cancer patients
No modification of the treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immune parameters (immunocytes phenotype)
Tidsramme: baseline up to 8 days (return to baseline)
|
Function tests and surface markers
|
baseline up to 8 days (return to baseline)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Long term outcome
Tidsramme: 5 years
|
General morbidity and mortality
|
5 years
|
|
Coagulation parameters (like platelet function) (substudy)
Tidsramme: perioperative period (up to 3 days)
|
Function tests and surface markers
|
perioperative period (up to 3 days)
|
|
Inflammatory markers (cytokines) (substudy)
Tidsramme: baseline up to 8 days (return to baseline)
|
Intracellular FACS and ELISA measures
|
baseline up to 8 days (return to baseline)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Patrice Forget, M.D., UCL
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011/30MAI/218
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