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Perioperative Evaluation of Immuno-inflammatory Parameters

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454856
First Posted: October 19, 2011
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain
  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 Forget Patrice, Université Catholique de Louvain:

Primary Outcome Measures:
  • Immune parameters (immunocytes phenotype) [ Time Frame: baseline up to 8 days (return to baseline) ]
    Function tests and surface markers


Secondary Outcome Measures:
  • Long term outcome [ Time Frame: 5 years ]
    General morbidity and mortality

  • Coagulation parameters (like platelet function) (substudy) [ Time Frame: perioperative period (up to 3 days) ]
    Function tests and surface markers

  • Inflammatory markers (cytokines) (substudy) [ Time Frame: baseline up to 8 days (return to baseline) ]
    Intracellular FACS and ELISA measures


Biospecimen Retention:   Samples Without DNA
Plasma and cells (PBMCs) frozen in cryotubes

Enrollment: 20
Study Start Date: October 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454856


Locations
Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
Principal Investigator: Patrice Forget, M.D. UCL
  More Information

Responsible Party: Forget Patrice, Principal Investigator, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01454856     History of Changes
Other Study ID Numbers: 2011/30MAI/218
First Submitted: October 5, 2011
First Posted: October 19, 2011
Last Update Posted: March 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases


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