Perioperative Evaluation of Immuno-inflammatory Parameters
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Purpose
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.
| Condition |
|---|
|
Combined Inflammatory and Immunologic Defect |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Perioperative Evaluation of Immuno-inflammatory Parameters |
- Immune parameters (immunocytes phenotype) [ Time Frame: baseline up to 8 days (return to baseline) ] [ Designated as safety issue: No ]Function tests and surface markers
- Long term outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]General morbidity and mortality
- Coagulation parameters (like platelet function) (substudy) [ Time Frame: perioperative period (up to 3 days) ] [ Designated as safety issue: No ]Function tests and surface markers
- Inflammatory markers (cytokines) (substudy) [ Time Frame: baseline up to 8 days (return to baseline) ] [ Designated as safety issue: No ]Intracellular FACS and ELISA measures
Biospecimen Retention: Samples Without DNA
Plasma and cells (PBMCs) frozen in cryotubes
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Cohort of patients
Inclusion Criteria:
- Surgical patients (and controls)
Exclusion Criteria:
- Immune disorders
Contacts and Locations| Contact: Patrice Forget, M.D. | +3227641821 | forgetpatrice@yahoo.fr |
| Belgium | |
| Cliniques universitaires Saint-Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Patrice Forget, M.D. +3227641821 forgetpatrice@yahoo.fr | |
| Principal Investigator: | Patrice Forget, M.D. | UCL |
More Information
No publications provided
| Responsible Party: | Forget Patrice, Principal Investigator, Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT01454856 History of Changes |
| Other Study ID Numbers: | 2011/30MAI/218 |
| Study First Received: | October 5, 2011 |
| Last Updated: | October 14, 2011 |
| Health Authority: | Belgium: Ethics Committee |
ClinicalTrials.gov processed this record on June 18, 2013