Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-22 @ 2:04 AM
Study NCT ID:
NCT01454856
Status:
TERMINATED
Last Update Posted:
2017-03-24
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Evaluation of Immuno-inflammatory Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565684', 'term': 'Combined Inflammatory and Immunologic Defect'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and cells (PBMCs) frozen in cryotubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune parameters (immunocytes phenotype)', 'timeFrame': 'baseline up to 8 days (return to baseline)', 'description': 'Function tests and surface markers'}], 'secondaryOutcomes': [{'measure': 'Long term outcome', 'timeFrame': '5 years', 'description': 'General morbidity and mortality'}, {'measure': 'Coagulation parameters (like platelet function) (substudy)', 'timeFrame': 'perioperative period (up to 3 days)', 'description': 'Function tests and surface markers'}, {'measure': 'Inflammatory markers (cytokines) (substudy)', 'timeFrame': 'baseline up to 8 days (return to baseline)', 'description': 'Intracellular FACS and ELISA measures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Combined Inflammatory and Immunologic Defect']}, 'descriptionModule': {'briefSummary': '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.\n\nThis will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.', 'detailedDescription': 'A significant number of published data can be concluded that surgery and anesthetic and analgesic techniques have an impact on immunity and inflammation.\n\nHowever, 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.\n\nIt 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.\n\nThis 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.\n\nThis will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical patients (and controls)\n\nExclusion Criteria:\n\n* Immune disorders'}, 'identificationModule': {'nctId': 'NCT01454856', 'briefTitle': 'Perioperative Evaluation of Immuno-inflammatory Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Perioperative Evaluation of Immuno-inflammatory Parameters', 'orgStudyIdInfo': {'id': '2011/30MAI/218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical cancer patients', 'description': 'No modification of the treatment'}, {'label': 'Non-surgical cancer patients', 'description': 'No modification of the treatment'}, {'label': 'Surgical non-cancer patients', 'description': 'No modification of the treatment'}, {'label': 'Non-surgical non-cancer patients', 'description': 'No modification of the treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Patrice Forget, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Forget Patrice', 'investigatorAffiliation': 'Université Catholique de Louvain'}}}}