Perioperative Evaluation of Immuno-inflammatory Parameters

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Université Catholique de Louvain
Sponsor:
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01454856
First received: October 5, 2011
Last updated: October 14, 2011
Last verified: October 2011
  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

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Immune parameters (immunocytes phenotype) [ Time Frame: baseline up to 8 days (return to baseline) ] [ Designated as safety issue: No ]
    Function tests and surface markers


Secondary Outcome Measures:
  • 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
Study Population

Cohort of patients

Criteria

Inclusion Criteria:

  • Surgical patients (and controls)

Exclusion Criteria:

  • Immune disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454856

Contacts
Contact: Patrice Forget, M.D. +3227641821 forgetpatrice@yahoo.fr

Locations
Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Patrice Forget, M.D.    +3227641821    forgetpatrice@yahoo.fr   
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
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 July 29, 2014