Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT06551194
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 972}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBD not meeting the DTT-IBD criteria', 'timeFrame': '3 months', 'description': 'In absence of prior literature describing the prevalence of DTT (our will be the first study) a sample size calculation can only be estimated based on clinical experience.\n\nBased on our clinical experience, assuming a Cohen effect size of 0.18, using a two-sided t-test with an alfa error of 0.05, 486 subjects in each group would be needed to detect a significant difference between the two (DTT and non-DTT). Therefore the total included population would be 486 x 2 = 972 patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Assessment of the Criteria and Risk Factors for DTT-IBD']}, 'descriptionModule': {'briefSummary': "Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time.\n\nIn 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common definition of 'difficult-to-treat' inflammatory bowel disease (IBD-IBD) to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies. According to the IOIBD criteria, IBD is defined by any of the following: failure of two or more advanced treatments with different mechanisms of action, postoperative recurrence of Crohn's disease after two or more bowel resections, pouchitis refractory to antibiotics, complex perianal Crohn's disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.\n\nAs the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019).", 'detailedDescription': "This is a multicentre retrospective cross-sectional study with two aims:\n\n1. To evaluate the prevalence of difficult-to-treat IBD\n2. To evaluate which and how demographic and clinical variables affect the risk of DTT-IBD\n\nThe subjects considered are adult patients (≥18 years) diagnosed with UC or CD followed at San Raffaele Hospital and Humanitas Research Hospital.\n\nCrohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time.\n\nIn 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common definition of 'difficult-to-treat' inflammatory bowel disease (IBD-IBD) to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies. According to the IOIBD criteria, IBD is defined by any of the following: failure of two or more advanced treatments with different mechanisms of action, postoperative recurrence of Crohn's disease after two or more bowel resections, pouchitis refractory to antibiotics, complex perianal Crohn's disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.\n\nAs the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18) diagnosed with IBD followed at San Raffaele Hospital and Humanitas Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (age ≥18)\n* Diagnosis of IBD: Crohn's disease (CD), ulcerative colitis (UC), or undetermined IBD (IBD-U)\n* A least one visit with a gastroenterology specialist after 01/01/2019\n\nExclusion Criteria:\n\n* Unconfirmed IBD diagnosis\n* Consultation with non-gastroenterology specialists\n* Consultation older than January 1st 2019\n* Pediatric patients (Age \\<18). Pediatric population will be excluded as the DTT-IBD criteria apply to adult patients only."}, 'identificationModule': {'nctId': 'NCT06551194', 'acronym': 'DTT-IBD', 'briefTitle': 'Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Ospedale San Raffaele'}, 'officialTitle': 'Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease: Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': 'DTT-IBD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC patients', 'description': 'Adult patients (age ≥18) diagnosed with UC', 'interventionNames': ['Other: prevalence of difficult-to-treat IBD']}, {'label': 'CD patients', 'description': 'Adult patients (age ≥18) diagnosed with UC', 'interventionNames': ['Other: prevalence of difficult-to-treat IBD']}], 'interventions': [{'name': 'prevalence of difficult-to-treat IBD', 'type': 'OTHER', 'description': 'To assess the prevalence and risk factors of difficult-to-treat IBD patients', 'armGroupLabels': ['CD patients', 'UC patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Lo Parigi, MD', 'role': 'CONTACT', 'email': 'parigi.tommaso@hsr.it', 'phone': '0226432756'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Tommaso Lo Parigi, MD', 'role': 'CONTACT', 'email': 'parigi.tommaso@hsr.it', 'phone': '02 2643 2756', 'phoneExt': '+39-022643275'}], 'overallOfficials': [{'name': 'Tommaso Lo Parigi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Gastroenterologist', 'investigatorFullName': 'Tommaso Lorenzo Parigi', 'investigatorAffiliation': 'IRCCS Ospedale San Raffaele'}}}}