Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 7:25 PM
Study NCT ID:
NCT05602103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cancer therapy-related cardiac dysfunction associated with anticancer drugs', 'timeFrame': 'from inception to the April 31, 2024', 'description': 'identification and description of cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase)'}], 'secondaryOutcomes': [{'measure': 'Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase)', 'timeFrame': 'from inception to the April 31, 2024', 'description': 'Disproportionnality analyses in Vigibase (IC025 and/or ROR) perfomed on cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)'}, {'measure': 'Description of the malignancies for which the incriminated drugs have been prescribed', 'timeFrame': 'from inception to the April 31, 2024', 'description': 'Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignancies', 'Cardiovascular Diseases', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to children and reported, or not, cancer therapy-related cardiac dysfunction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)\n* related to children\n* and reported, or not, cancer therapy-related cardiac dysfunction\n\nExclusion Criteria:\n\n* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients'}, 'identificationModule': {'nctId': 'NCT05602103', 'briefTitle': 'Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction Reporting in Pediatrics - Analysis of the WHO Pharmacovigilance Database', 'orgStudyIdInfo': {'id': 'Pharmaco_112022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'use of anticancer drugs in monotherapy or in combination therapy', 'type': 'DRUG', 'description': 'Cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs will be identify and describe'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Joachim Alexandre, MD, PhD', 'role': 'CONTACT', 'email': 'alexandre-j@chu-caen.fr', 'phone': '+330231064770'}], 'overallOfficials': [{'name': 'Joachim Alexandre, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caen Normandy University Hospital, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}