Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 8:49 PM
Study NCT ID:
NCT06664528
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cardiotoxicity', 'timeFrame': '24 months', 'description': 'Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022.'}, {'measure': 'Identification of major cardiovascular adverse events (MACE)', 'timeFrame': '24 months', 'description': 'Identification of cardiovascular death, non-cardiovascular death and hospitalization for cardiac causes (congestive heart failure, major arrhythmias) both during the antineoplastic treatments and in the long-survivors population.'}], 'secondaryOutcomes': [{'measure': 'Identification of early predictors of cardiotoxicity', 'timeFrame': '24 months', 'description': 'Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Toxicity', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, treated with cardiotoxic therapies.\n\nThe main purposes of the study are the following:\n\n* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs.\n* Identify any subgroups more likely to develop distant major adverse cardiovascular events (MACE).\n* Evaluate the usefulness of clinical, biohumoral and echocardiographic parameters for early diagnosis of cardiotoxicity.\n\nParticipants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendation of the current guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.', 'detailedDescription': 'The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, exposed to potentially-cardiotoxic therapies.\n\nThe main purposes of the study are the following:\n\n* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs.\n* Identify any subgroups of patients more likely to develop distant major adverse cardiovascular events (MACE).\n* Evaluate the usefulness of clinical, bio-humoral and echocardiographic parameters for early diagnosis of cardiotoxicity.\n\nParticipants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendations of the available guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with cancer treated with potentially cardiotoxic anticancer drugs, with complete clinical, laboratory, electrocardiographic and echocardiographic data obtained at the first cardio-oncologic evaluation and at least at one follow-up visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 at the time of evaluation\n* Patients treated with potentially cardiotoxic anticancer drugs\n* Patients for which complete clinical, electrocardiographic and echocardiographic data are available at first evaluation and at least at one follow-up visit.\n\nExclusion Criteria:\n\n* Patients under the age of 18 at the time of evaluation\n* Patients whose documentation of the first visit is not available\n* Patients for whom it is not possible to obtain follow-up information through a medical visit or by telephone\n* Patient with poor acoustic window for echocardiographic examination.\n* Refusal of informed consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06664528', 'acronym': 'CV_CANCER', 'briefTitle': 'Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study', 'orgStudyIdInfo': {'id': '6977'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECHOCARDIOGRAPHY', 'type': 'DIAGNOSTIC_TEST', 'description': 'A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.'}, {'name': 'ELECTROCARDIOGRAPHY (ECG)', 'type': 'DIAGNOSTIC_TEST', 'description': 'An ECG tracing will be obtained during each cardio-oncologic evaluation.'}, {'name': 'LABORATORY TESTS', 'type': 'DIAGNOSTIC_TEST', 'description': 'The cardiac biomarkers high-sensitivity troponin I and N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be dosed according to the current recommendations of Cardio-Oncology Guidelines.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Lombardo', 'role': 'CONTACT', 'email': 'antonella.lombardo@policlinicogemelli.it', 'phone': '+390630157070'}, {'name': 'Massimiliano Camilli', 'role': 'CONTACT', 'email': 'massimiliano.camilli.91@gmail.com'}, {'name': 'Antonella Lombardo', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Massimiliano Camilli', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Priscilla Lamendola', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcello Viscovo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Hohaus', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Antonella Lombardo', 'role': 'CONTACT', 'email': 'antonella.lombardo@policlinicogemelli.it', 'phone': '+390630157070'}], 'overallOfficials': [{'name': 'Antonella Lombardo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}