Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04774627
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pancytopenia Related to PARP Inhibitors (PancytoRIB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067856', 'term': 'Poly(ADP-ribose) Polymerase Inhibitors'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'C531549', 'term': 'rucaparib'}, {'id': 'C545685', 'term': 'niraparib'}, {'id': 'C586365', 'term': 'talazoparib'}, {'id': 'C521013', 'term': 'veliparib'}, {'id': 'C000707927', 'term': 'pamiparib'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pancytopenia reports related to PARPi.', 'timeFrame': 'From inception to Feb, 2021', 'description': "Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports."}], 'secondaryOutcomes': [{'measure': 'Description of the latency period since first PARPi exposure.', 'timeFrame': 'From inception to Feb, 2021'}, {'measure': 'Description of the fatality rate.', 'timeFrame': 'From inception to Feb, 2021'}, {'measure': 'Description of patients who experienced co-reported adverse events', 'timeFrame': 'From inception to Feb, 2021'}]}, '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 adverse events such as pancytopenia. Today, data about pancytopenia are scarce.\n\nThe objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib 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 pancytopenia related to PARPi."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients treated with PARPi and experiencing pancytopenia.', 'healthyVolunteers': False, '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 (none) and pamiparib (none).\n\nExclusion Criteria: chronology not compatible between the PARPi and adverse event.'}, 'identificationModule': {'nctId': 'NCT04774627', 'briefTitle': 'Pancytopenia Related to PARP Inhibitors (PancytoRIB)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': "Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)", 'orgStudyIdInfo': {'id': 'Pharmaco 20200210'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PARP inhibitor', 'type': 'DRUG', 'otherNames': ['olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib'], 'description': 'All patients treated at least with 1 PARPi'}]}, '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'}}}}