Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 7:11 AM
Study NCT ID:
NCT06250361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of patient's visits to doctors between the appearance of the first symptoms and the diagnosis of the disease.", 'timeFrame': 'Day 1 from appearence of first symptoms and the diagnosis of the disease.', 'description': "Number of patient's visits to doctors between the appearance of the first symptoms and the diagnosis of the disease."}, {'measure': 'Number of exams performed between the appearance of the first symptoms and the diagnosis of the disease.', 'timeFrame': 'Day 1 from appearence of first symptoms and the diagnosis of the disease.', 'description': 'Number of exams performed between the appearance of the first symptoms and the diagnosis of the disease.'}, {'measure': 'Number of medical specialties consulted between the appearance of the first symptoms and the diagnosis of the disease.', 'timeFrame': 'Day 1 from appearence of first symptoms and the diagnosis of the disease.', 'description': 'Number of medical specialties consulted between the appearance of the first symptoms and the diagnosis of the disease.'}], 'secondaryOutcomes': [{'measure': 'Number of predictive factors associated with a delayed diagnosis', 'timeFrame': 'Day 1', 'description': 'Number of predictive factors associated with a delayed diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD', 'CROHN', 'CD'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the factors associated with a delayed diagnosis and/or an immediately complicated disease for CD patients.\n\nA questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.', 'detailedDescription': 'Number of patients expected : at least 600, coming from all types of practices (ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice)).\n\nRecruitment period : 1 year\n\nPrimary endpoint : The primary endpoint is the description of the factors linked to:\n\n* The IBD\n* The patient (see patient questionnaire in annex 1)\n* The health care system\n* The patient\'s self-care\n\nSecondary endpoint :\n\n* Validation of the "red flags" in a prospective cohort.\n* Comparison with the EPIMAD population, especially the location and severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease, going to ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice) centres, who have been diagnosed within the year before the inclusion visit.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Crohn's disease diagnosed less than a year prior to inclusion\n* Written consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's disease more than one year before inclusion\n* Patient protected by the law\n* Patient without health cover"}, 'identificationModule': {'nctId': 'NCT06250361', 'acronym': 'FAST', 'briefTitle': "Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, 'officialTitle': "Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease: the FAST Study", 'orgStudyIdInfo': {'id': 'GETAID-2023-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire completion', 'type': 'OTHER', 'description': 'A questionnaire will be completed by the participant and their gastroenterologist. Estimated completion time is 30 minutes for the patient, 10 minutes for the gastroenterologist.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Charlotte Mailhat, PhD', 'role': 'CONTACT', 'email': 'cmailhat@getaid.org', 'phone': '+ 33 9 72 57 61 60'}], 'overallOfficials': [{'name': 'Stéphane Nahon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}