Perioperative Evaluation of Immuno-inflammatory Parameters | NCT01454856

Studies
Perioperative Evaluation of Immuno-inflammatory Parameters

NCT01454856

Sponsor

Université Catholique de Louvain

Status

Terminated

Last Update Posted

Mar 24, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Combined Inflammatory and Immunologic Defect

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 5, 2011

First Submission Date that Met QC Criteria

Oct 14, 2011

First Posted Date

Oct 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2017

Last Update Posted Date

Mar 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Forget Patrice, Principal Investigator, Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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 will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune parameters (immunocytes phenotype)	Function tests and surface markers	baseline up to 8 days (return to baseline)

Secondary Outcomes

Measure	Description	Time Frame
Long term outcome	General morbidity and mortality	5 years
Coagulation parameters (like platelet function) (substudy)	Function tests and surface markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgical patients (and controls)

Exclusion Criteria:

Immune disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cohort of patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrice Forget, M.D.	UCL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

Condition Browse Module

MeSH Terms

ID	Term
C565684	Combined Inflammatory and Immunologic Defect

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided