Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT06086132
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All causes mortality', 'timeFrame': 'For approximately a median of 3 years', 'description': 'Occurrence of all cause death'}, {'measure': 'Cardiovascular mortality', 'timeFrame': 'For approximately a median of 3 years', 'description': 'Occurrence of cardiovascular mortality'}, {'measure': 'Cancer therapy-related cardiovascular toxicity', 'timeFrame': 'For approximately a median of 3 years', 'description': 'Occurrence of cancer therapy-related cardiovascular toxicity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Related Cardiovascular Toxicity']}, 'referencesModule': {'references': [{'pmid': '36017568', 'type': 'BACKGROUND', 'citation': 'Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Confirmed diagnosis of cancer undergoing treatment', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years old or older\n* Capable of giving informed consent\n* Diagnosis of cancer scheduled for treatment according to treating physician's discretion\n* Life expectancy \\>1 year\n* For the prospective validation of HFA-ICOS risk score validation: Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Not able to give informed consent\n* Life expectancy \\<1 year\n* Advanced-stage cancer not eligible for treatment (subjects with an indication of palliative care) according to treating physician's"}, 'identificationModule': {'nctId': 'NCT06086132', 'briefTitle': 'Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)', 'orgStudyIdInfo': {'id': 'ISACS CARDIONCO-PREDICT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer', 'description': 'Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs.\n\n(Non-interventional prospective patient registry)', 'interventionNames': ['Combination Product: Prospective validation of the HFA-ICOS risk score in a subset of subjects with newly diagnosed breast cancer and undergoing treatment with anthracyclines analogues with or without radiotherapy']}, {'label': 'Female and Male', 'description': "Diagnosis of cancer scheduled for treatment according to the treating physician's discretion.\n\n(Non-interventional patient registry)"}], 'interventions': [{'name': 'Prospective validation of the HFA-ICOS risk score in a subset of subjects with newly diagnosed breast cancer and undergoing treatment with anthracyclines analogues with or without radiotherapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Non-interventional patient registry'], 'description': 'Follow-up visits at baseline, 3-months, and 1-year', 'armGroupLabels': ['Breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Palermo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Skopje', 'status': 'RECRUITING', 'country': 'North Macedonia', 'facility': 'Ss. Cyril and Methodius University in Skopje, University Clinic', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'University of Belgrade, Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'University of Belgrade, Clinical Hospital Center Bezanijska kosa', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Edina Cenko', 'role': 'CONTACT', 'email': 'dimec.epicardio@unibo.it', 'phone': '+3905121444911'}, {'name': 'Maria Bergami', 'role': 'CONTACT', 'email': 'dimec.epicardio@unibo.it', 'phone': '+3905121444911'}], 'overallOfficials': [{'name': 'Prof. Olivia Manfrini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bologna'}, {'name': 'Prof. Giuseppina Novo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Olivia Manfrini, MD', 'investigatorAffiliation': 'University of Bologna'}}}}