Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-29 @ 7:47 AM
Study NCT ID:
NCT02869256
Status:
UNKNOWN
Last Update Posted:
2017-11-21
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Central Database Recording of Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance of the management of patients with chronic myeloid leukemia compared to the guidelines', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic myeloid leukemia', 'practices evaluation'], 'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.', 'detailedDescription': 'Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .\n\nIndeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with chronic myeloid leukemia diagnosis in chronic phase', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast\n* male or female patient aged 18 years or more\n* Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information\n* Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié\n\nExclusion Criteria:\n\n* none"}, 'identificationModule': {'nctId': 'NCT02869256', 'acronym': 'LMC', 'briefTitle': 'Regional Central Database Recording of Chronic Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Regional Central Database Recording of Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'IB2014-LMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Practices evaluation', 'type': 'OTHER', 'description': 'Practices evaluation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier FITOUSSI', 'role': 'CONTACT'}], 'facility': 'Polyclinique Bordeaux Nord', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Xavier Mahon, MD PhD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel Etienne', 'role': 'CONTACT'}], 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '40100', 'city': 'Dax', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François LIFERMANN', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Dax', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'city': 'Libourne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joël CECCALDI', 'role': 'CONTACT'}], 'facility': 'Centre hospitalier Libourne', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '64000', 'city': 'Pau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne Dagada', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}], 'centralContacts': [{'name': 'Gabriel etienne, MD', 'role': 'CONTACT', 'email': 'G.Etienne@bordeaux.unicancer.fr'}, {'name': 'Simone Mathoulin-Pelissier, MD PhD', 'role': 'CONTACT', 'email': 'S.Mathoulin@bordeaux.unicancer.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}