Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06268535
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D016609', 'term': 'Neoplasms, Second Primary'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36580288}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024', 'description': 'A disproportionality analysis is carried out using stepwise selection procedure and taking into account confounding factors (factors known to promote heart failure or cardiac dysfunction).'}], 'secondaryOutcomes': [{'measure': 'Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024', 'description': 'The investigators describe the profile of cases of heart failure of cardiac dysfunction among cancer therapies associated with heart failure or cardiac dysfunction in the main analysis. We particularly focused on factors known to promote heart failure.'}, {'measure': 'Description of the pathologies (cancer) for which the incriminated drugs have been prescribed', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024'}, {'measure': 'Description of the drug-drug interactions associated with adverse events', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cancer, Therapy-Related']}, 'referencesModule': {'references': [{'pmid': '40272201', 'type': 'DERIVED', 'citation': 'Legallois D, Da Silva A, Alexandre J, Milliez P, Sabatier R, Blanchart K, Plane AF, Font J, Chretien B, Dolladille C. Identification of anticancer drugs associated to cancer therapy-related cardiac dysfunction: a VigiBase(R) disproportionality analysis. Eur Heart J Cardiovasc Pharmacother. 2025 Aug 12;11(5):459-468. doi: 10.1093/ehjcvp/pvaf027.'}]}, 'descriptionModule': {'briefSummary': "Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.\n\nAmong these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.\n\nPatients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.\n\nThe explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.\n\nUsing VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patients in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024 included with at least one anticander drug.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case reported in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024\n* Patients treated with FDA and/or EMA approved cancer therapies (approval the 30th September 2023).'}, 'identificationModule': {'nctId': 'NCT06268535', 'briefTitle': 'Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database', 'orgStudyIdInfo': {'id': 'CaenUH_DL_1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023', 'type': 'DRUG', 'description': 'Disproportionality analysis studying the association between cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023 and heart failure or cardiac dysfunction in the World Health Organization pharmacovigilance database.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}