Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT03404557
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state', 'timeFrame': 'at day 1', 'description': 'Compare concentrations of different protein types in the supernatant of macrophages from patients with CD through proteomic approaches, compared with patients with UC or controls.'}], 'secondaryOutcomes': [{'measure': 'Comparison of concentrations of different protein types in the supernatant of macrophages', 'timeFrame': 'at day 1'}, {'measure': 'presence of subgroups of patients with CD based on the proteomic profile of their macrophages.', 'timeFrame': 'at day 1'}, {'measure': 'association between these subgroups of patients with CD and biological parameters.', 'timeFrame': 'at day 1'}, {'measure': 'associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status', 'timeFrame': 'at day 1'}, {'measure': 'associations between the levels of entry, survival and multiplication of AIEC bacteria', 'timeFrame': 'at day 1'}, {'measure': 'impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD', 'timeFrame': 'at day 1'}, {'measure': 'associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status', 'timeFrame': 'at day 1'}, {'measure': 'associations between the Proteomic profile (s) of tissue macrophages and their AIEC status', 'timeFrame': 'at day 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'Ulcerative colitis', 'Macrophages', 'Adherent-Invasive Escherichia coli', 'Proteomic analysis'], 'conditions': ["Crohn's Disease", 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.\n\nThat's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.", 'detailedDescription': 'The macrophages characterization will be realized at a basal state and in response or not to AIEC.\n\nInvestigator aimed to 1) better understand the differences between macrophages of CD patients, UC patients and healthy volunteers but also the impact of AIEC infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in CD macrophages that could represent, in a long term, a potential therapeutic target of CD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\- Crohn's Disease or ulcerative colitis or healthy volunteers\n* Age \\> 18 years\n* Patients benefiting from the health insurance plan\n* Patients who can read and attest to understanding the information note and informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Under guardianship or curatorship\n* Refusing the genetic part of the study"}, 'identificationModule': {'nctId': 'NCT03404557', 'acronym': 'ROMAN', 'briefTitle': "Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli", 'orgStudyIdInfo': {'id': 'CHU-370'}, 'secondaryIdInfos': [{'id': '2017-A00667-46', 'type': 'OTHER', 'domain': '2017-A00667-46'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's Disease patients group", 'description': '44 patients', 'interventionNames': ['Other: Proteomic analysis']}, {'label': 'Ulcerative Colitis patients group', 'description': '22 patients', 'interventionNames': ['Other: Proteomic analysis']}, {'label': 'Healthy volunteers group', 'description': '22 patients', 'interventionNames': ['Other: Proteomic analysis']}], 'interventions': [{'name': 'Proteomic analysis', 'type': 'OTHER', 'description': "Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli", 'armGroupLabels': ["Crohn's Disease patients group", 'Healthy volunteers group', 'Ulcerative Colitis patients group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Anthony BUISSON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire M2Ish', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}