Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-03 @ 7:04 AM
Study NCT ID:
NCT06018259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioactive Lipids & PBMC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PBMC proliferation, differentiation or activation', 'timeFrame': 'Throughout the study, an average of 5,5 years', 'description': 'Expression of inflammatory markers (e.g. cytokines: IL-1, IL-6,...), by RT-qPCR and/or ELISA'}], 'secondaryOutcomes': [{'measure': 'Correlation between the expression of enzymes or receptors and the PBMC activation state', 'timeFrame': 'Throughout the study, an average of 5,5 years', 'description': 'Expression of the receptors known to mediate the effects of the lipids studied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The investigators aim at harvesting PBMC from healthy donors to study the effect of the lipids mediators of interest. After isolation from the blood, PBMC will be activated as largely reported in the literature in the presence or absence of the tested lipids. The effect will be assessed by quantifying the expression of inflammatory markers. The expression of the receptors and enzymes potentially regulating the effects of the studied lipids will also be assessed.', 'detailedDescription': 'Data from the scientific literature support the hypothesis that bioactive lipids play an important role in inflammatory disorders. The levels of these bioactive lipids are altered in several pathophysiological conditions with an inflammatory component. The investigators and others have demonstrated that bioactive lipids affect the inflammatory tone in vivo in murine models as well as in in vitro models. However, confirming the translational value of these data is not easy in clinical studies. PBMC-based experiments are a powerful tool for us to validate our previous observations and will offer translational added value supporting further clinical investigations.\n\nThus, here the investigators aim at harvesting PBMC from healthy donors and use them to study the effect of the lipid mediators of interest (i.e. those showing interesting properties in our preclinical models). Blood will be collected from healthy volunteers, and PMBC isolated based on their density. After isolation from the blood, PBMC will be activated as largely reported in the literature (e.g. using phytohemagglutinin or lipopolysaccharides) in the presence or absence of the tested lipids. The effect will be assessed by quantifying the expression of inflammatory markers (by RT-qPCR and/or ELISA). The expression of the receptors and enzymes potentially regulating the effects of the studied lipids will be also assessed (by RT-qPCR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers must be able to give informed consent to be included in the study.\n* no chronic inflammatory disease\n* no acute inflammation\n\nExclusion Criteria:\n\n* Men and women aged less than 18 years\n* Pregnant women\n* Prior diagnosis of a chronic inflammatory disease (for instance IBD, COPD, lupus, MS, etc. This is not an exhaustive list).\n* Recent (\\<21 days) episode of acute inflammation or immune-altering event (e.g. cold, flu, vaccine, …).\n* Chronic or recent use of drugs interfering with the immune / inflammatory response. Examples include (and are not limited to) NSAIDs, corticosteroids, aspirin, mABs, etc.\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT06018259', 'briefTitle': 'Bioactive Lipids & PBMC', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Investigations on the Role of Bioactive Lipids in the Control of PBMC Activation and Differentiation.', 'orgStudyIdInfo': {'id': 'LIP-PBMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'description': 'One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them', 'interventionNames': ['Procedure: healthy volunteers blood sampling']}], 'interventions': [{'name': 'healthy volunteers blood sampling', 'type': 'PROCEDURE', 'description': 'One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them PBMC will be activated in vitro (e.g. using LPS or PHA) in the presence or absence of the lipid of interest.', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Giulio Muccioli, prof', 'role': 'CONTACT', 'email': 'giulio.muccioli@uclouvain.be'}, {'name': 'Mireille Al Houayek, PhD', 'role': 'CONTACT', 'email': 'mireille.alhouayek@uclouvain.be'}], 'overallOfficials': [{'name': 'Giulio Muccioli, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}