Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 9:23 AM
Study NCT ID:
NCT06275334
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dinutuximab Beta at the HUS and the Toulouse Oncopole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse.', 'timeFrame': 'The period concerned is from January 1, 1998 to December 31, 2023.', 'description': 'This study is retrospective and consists of comparing two methods of treating neuroblastoma in two health establishments and covers the period from January 1, 1998 to December 31, 2023.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroblastoma', 'Dinutuximab Beta', 'DNB'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged 2 years to 25 years suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 2 years to 25 years\n* Male or female gender\n* Subjects suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.\n* Subject (and/or holders of parental authority) not opposing, after information, the reuse of the child's data for the purposes of this research and agreeing to respond to the quality of life survey.\n\nExclusion Criteria:\n\n* Patient or parents of the minor having expressed their opposition to participating in the study.\n* specific clinical forms of the disease,\n* interfering treatments and associated diseases."}, 'identificationModule': {'nctId': 'NCT06275334', 'acronym': 'DNB', 'briefTitle': 'Dinutuximab Beta at the HUS and the Toulouse Oncopole', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Dinutuximab Beta at the Strasbourg University Hospitals (HUS) and the Toulouse Oncopole: Comparative Analysis of Patient Pathways, Associated Costs and Quality of Life According to Traditional Hospitalization or Hospital at Home (HAD)', 'orgStudyIdInfo': {'id': '9133'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne EL AATMANI, Pharm, PhD', 'role': 'CONTACT', 'email': 'Anne.ELAATMANI@chru-strasbourg.fr', 'phone': '33 3 88 12 78 06'}, {'name': 'Emilie BERTHON, Pharm, PhD', 'role': 'CONTACT', 'email': 'emilieberthon@orange.fr', 'phone': '33 3 88 12 78 06'}, {'name': 'Anne EL AATMANI, Pharm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emilie BERTHON, PhamD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie PERRIAT, PhamD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Pharmacie - Stérilisation - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne EL AATMANI, Pharm, PhD', 'role': 'CONTACT', 'email': 'Anne.ELAATMANI@chru-strasbourg.fr', 'phone': '33 3 88 12 78 06'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}