Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-07 @ 10:00 AM
Study NCT ID:
NCT06580418
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist', 'timeFrame': '20 months', 'description': 'Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist'}], 'secondaryOutcomes': [{'measure': 'Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound', 'timeFrame': '26 months', 'description': 'Measurement of pro-inflammatory cytokine concentrations (pg/ml)'}, {'measure': 'Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound', 'timeFrame': '26 months', 'description': 'RNAseq analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.\n\nThe main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population that will be recruited for this study will be composed of patients with UC or CD under endoscopic surveillance for monitoring the clinical activity of their disease.\n\nThe recruited patients will firstly sign the informed consent before undergoing the same day the blood withdrawal and endoscopy according to standard of care practice in the dedicated department, under the direction of the Gastroenterology and Digestive Endoscopy operative unit of the San Raffaele Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 18 and 60 years\n* Signed informed consent\n* Ulcerative colitis (UC) patients with active disease\n* Crohn's disease (CD) patients with active disease\n\nExclusion Criteria:\n\n* UC or CD patients in remission\n* Patients between 18 and 60 years without informed consent"}, 'identificationModule': {'nctId': 'NCT06580418', 'acronym': 'TIME', 'briefTitle': 'Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inotrem'}, 'officialTitle': 'Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model', 'orgStudyIdInfo': {'id': 'TIME'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulcerative colitis (UC)', 'description': '20 patients with moderate to severe UC under endoscopic surveillance for their disease', 'interventionNames': ['Other: Additional biopsies and blood samples']}, {'label': "Crohn's Disease (CD)", 'description': '20 patients with moderate to severe CD under endoscopic surveillance for their disease', 'interventionNames': ['Other: Additional biopsies and blood samples']}], 'interventions': [{'name': 'Additional biopsies and blood samples', 'type': 'OTHER', 'description': 'During the endoscopic procedure planned for IBD patients following standard clinical practice, the endoscopist will decide the number and location of additional biopsy samples (up to 8) collected for the study. Participation in this study also requires the removal of three additional blood samples.', 'armGroupLabels': ["Crohn's Disease (CD)", 'Ulcerative colitis (UC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvio Danese, MD', 'role': 'CONTACT', 'email': 'danese.silvio@hsr.it', 'phone': '+39 02.26431'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inotrem', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IRCCS San Raffaele', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}