Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:02 PM
Study NCT ID:
NCT04696250
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D000091369', 'term': 'Immunomodulating Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events of antineoplastic and immunomodulating agents', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025', 'description': 'Identification and report of adverse event of antineoplastic and immunomodulating agents. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms'}], 'secondaryOutcomes': [{'measure': 'Causality assessment of reported adverse events according to the WHO system', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025'}, {'measure': 'Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025'}, {'measure': 'Description of the time from anticancer drug initiation and the occurrence of the adverse event', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025'}, {'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 January 1st 2025'}, {'measure': 'Description of the cancer for which the incriminated drugs have been prescribed', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025'}, {'measure': 'Description of the population of patients having adverse event', 'timeFrame': 'Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '39627133', 'type': 'DERIVED', 'citation': "L'Orphelin JM, Da Silva A, Cabon J, Alexandre J, Dolladille C. Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals. BMJ Open. 2024 Dec 3;14(12):e091708. doi: 10.1136/bmjopen-2024-091708."}]}, 'descriptionModule': {'briefSummary': "Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).", 'detailedDescription': 'The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Antineoplastic and immunomodulating agents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case reported in the World Health Organization (WHO) database of individual safety case reports at the time of the extraction\n* Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms\n* Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.\n\nExclusion Criteria:\n\n* Chronology not compatible between the drug and the toxicity'}, 'identificationModule': {'nctId': 'NCT04696250', 'acronym': 'AVATAR', 'briefTitle': 'Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)', 'orgStudyIdInfo': {'id': 'Pharmaco112020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adverse Events associated with Antineoplastic and Immunomodulating Agents', 'description': 'Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by anticancer drugs, with a chronology compatible with the drug toxicity', 'interventionNames': ['Drug: Antineoplastic and Immunomodulating Agents']}], 'interventions': [{'name': 'Antineoplastic and Immunomodulating Agents', 'type': 'DRUG', 'description': 'Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L', 'armGroupLabels': ['Adverse Events associated with Antineoplastic and Immunomodulating Agents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Basse Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joachim Alexandre, MD', 'role': 'CONTACT', 'email': 'alexandre-j@chu-caen.fr', 'phone': '+33231064670'}], 'facility': 'Alexandre Joachim', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}