Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT02331303
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2015-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Utilization Study of Radium-223 in Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581106', 'term': 'radium Ra 223 dichloride'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2015-01-02', 'studyFirstSubmitQcDate': '2015-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of being women of Xofigo use', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of being children of Xofigo use', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV', 'timeFrame': 'Up to 2 years'}, {'measure': 'Dosage of Xofigo (kBq/kg)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Proportion of participants of dose outside label recommendation', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. It will consist of mCRPC patients and potentially some other patient groups in whom Xofigo may be used off-label including women, children, cancer patients having bone metastasis with a diagnosis other than CRPC, and patients with repeated courses of treatment or in excess of those recommended in the label. This study will be based on data extracted from two pre-established data sources: 15 nuclear medicine centers across Sweden and the Swedish National Cancer Registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study\n\nExclusion Criteria:\n\n* Patients receiving Xofigo in a clinical trial will not be included in this study'}, 'identificationModule': {'nctId': 'NCT02331303', 'briefTitle': 'A Drug Utilization Study of Radium-223 in Sweden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Drug Utilization Study of Xofigo Use in Sweden', 'orgStudyIdInfo': {'id': '17399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden.\n\nThis study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period.', 'interventionNames': ['Other: Radium-223 dichloride (Xofigo, BAY88-8223)']}], 'interventions': [{'name': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'type': 'OTHER', 'description': 'Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}