Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:59 AM
Study NCT ID:
NCT04774406
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2021-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'C531549', 'term': 'rucaparib'}, {'id': 'C545685', 'term': 'niraparib'}, {'id': 'C586365', 'term': 'talazoparib'}, {'id': 'C521013', 'term': 'veliparib'}, {'id': 'C000707927', 'term': 'pamiparib'}, {'id': 'C000722917', 'term': 'fluzoparib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2336}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypertension reports related to PARPi.', 'timeFrame': 'From inception to 16 Feb, 2023', 'description': "Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.\n\nThe objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.", 'detailedDescription': "Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients treated with PARPi and experiencing hypertension.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,\n* patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).\n\nExclusion Criteria:\n\n-chronology not compatible between the PARPi and adverse event'}, 'identificationModule': {'nctId': 'NCT04774406', 'briefTitle': 'Arterial Hypertension Related to PARP Inhibitors (ArteRIB)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)', 'orgStudyIdInfo': {'id': 'Pharmaco 16022023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'parp inhibitors', 'description': 'All patients treated at least with 1 PARPi', 'interventionNames': ['Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib']}], 'interventions': [{'name': 'olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib', 'type': 'DRUG', 'description': 'All patients treated at least with 1 PARPi (alone or in combination)', 'armGroupLabels': ['parp inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Alexandre Joachim', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}