Combined Inflammatory and Immunologic DefectNCT01454856
Perioperative Evaluation of Immuno-inflammatory Parameters
An observational study of Combined Inflammatory and Immunologic Defect, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Combined Inflammatory and Immunologic Defect
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of patients
Who may be able to join
- Surgical patients (and controls)
Who cannot join
- Immune disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Combined Inflammatory and Immunologic Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune parameters (immunocytes phenotype)
Function tests and surface markers
Measured: baseline up to 8 days (return to baseline)
Secondary outcomes (3)
Long term outcome
General morbidity and mortality
Measured: 5 years
Coagulation parameters (like platelet function) (substudy)
Function tests and surface markers
Measured: perioperative period (up to 3 days)
Inflammatory markers (cytokines) (substudy)
Intracellular FACS and ELISA measures
Measured: baseline up to 8 days (return to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Inflammatory and Immunologic DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forget Patrice, Université Catholique de Louvain
- Investigators
- Patrice Forget, M.D., Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454856
- Sponsor's protocol ID
- 2011/30MAI/218
- Status last verified
- Mar 2017
- First submitted
- 5 Oct 2011
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Evaluation of Immuno-inflammatory Parameters
- ClinicalTrials.gov ID
- NCT01454856
- Acronym / sponsor ID
- 2011/30MAI/218
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients
Key inclusion criteria (1 listed)
- Surgical patients (and controls)
Key exclusion criteria (1 listed)
- Immune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune parameters (immunocytes phenotype)
Time frame: baseline up to 8 days (return to baseline)
Function tests and surface markers
3 secondary outcomes
Long term outcome
Time frame: 5 years
Coagulation parameters (like platelet function) (substudy)
Time frame: perioperative period (up to 3 days)
Inflammatory markers (cytokines) (substudy)
Time frame: baseline up to 8 days (return to baseline)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Forget, M.D. principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Inflammatory and Immunologic Defect, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune parameters (immunocytes phenotype) (time frame: baseline up to 8 days (return to baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.