Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-31 @ 2:48 AM
Study NCT ID:
NCT04681456
Status:
TERMINATED
Last Update Posted:
2021-05-14
First Post:
2020-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Cancer Oncology Radiation Evidence Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The study was stopped in order to reconfigure it as a PhaseII/III study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants will have their responses to radiotherapy after treatment of non-melanoma skin cancer measured and reported as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.', 'timeFrame': '5 years', 'description': 'To assess participant safety following treatment of non-melanoma skin cancers with radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-melanoma Skin Cancer']}, 'descriptionModule': {'briefSummary': 'To collect and analyze long term safety and efficacy outcomes of patients undergoing radiotherapy for non-melanoma skin cancer. A target of 400 VMAT-treated sites is set which is estimated to be identified in approximately 350 participants. Participants referred for radiotherapy for the management of non-melanoma skin cancer.', 'detailedDescription': 'The Registry will collect information on key clinical indications and patient reported outcomes to assess the safety and efficacy of VMAT radiotherapy. Data that will be collected includes baseline data of demographic, relevant medical history, photographs, treatment schedule, and treatment outcomes. Data may be collected retrospectively in regard to previous relevant medical history, prior treatments and outcomes as well as prospectively, including treatment schedule and treatment outcomes of radiotherapy treatment.\n\nThe Registry aims to assess the safety and outcomes of treatment for up to 5 years. This Registry will be the first of its kind in the US and will provide a basis for a number of potential research publications. The Registry will also give insights into treatment delivery and potentially facilitate future improvements in patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited based on their potential eligibility to receive VMAT widefield radiotherapy treatment of their NMSC. The RO will assess if the condition is suitable for VMAT treatment, and if so, will discuss the Registry with the participant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* Diagnosed with a treatable non-melanoma skin cancer by referring medical practitioner\n* Eligible to be treated using widefield (\\>50cm2) VMAT radiotherapy as determined by RO\n* Patient has provided written informed consent.\n\nExclusion Criteria:\n\n♦ Patients who do not consent to their involvement in the Registry.'}, 'identificationModule': {'nctId': 'NCT04681456', 'acronym': 'SCORER', 'briefTitle': 'Skin Cancer Oncology Radiation Evidence Registry', 'organization': {'class': 'OTHER', 'fullName': 'GenesisCare USA'}, 'officialTitle': 'Skin Cancer Oncology Radiation Evidence Registry', 'orgStudyIdInfo': {'id': 'GCUSA-2020-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'There is no medical intervention for the purposes of this Registry.', 'type': 'BEHAVIORAL', 'description': 'There is no medical intervention for the purposes of this Registry.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'GenesisCare USA', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}], 'overallOfficials': [{'name': 'Constantine Mantz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GenesisCare USA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2021 or 2022', 'ipdSharing': 'YES', 'description': 'All other researchers belong to the same organization and could potentially have access to all data gathered.', 'accessCriteria': 'Data will be stored on secured servers of the sponsoring organization and will be password protected with limited access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GenesisCare USA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}