Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 9:31 PM
Study NCT ID:
NCT06605833
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-01
First Post:
2024-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance rate', 'timeFrame': '12 months', 'description': 'total number of patients consented divided by the number of patients invited for the study'}], 'secondaryOutcomes': [{'measure': 'Adherence rate', 'timeFrame': '12 months', 'description': 'proportion of patients completing all the scheduled cardiac screening tests divided by the number of patients enrolled in the study'}, {'measure': 'Recruitment rate', 'timeFrame': '12 months', 'description': 'Number of patients recruited on average per month in each site, and overall'}, {'measure': 'Reasons for non-adherence or declining to consent', 'timeFrame': '12 months', 'description': 'Reasons for non-adherence or declining to consent'}, {'measure': 'Difference in adherence rates', 'timeFrame': '12 months', 'description': 'Difference in adherence rates between adjuvant early disease setting and metastatic setting'}, {'measure': 'Proportion of patients who experience cardiovascular irAEs', 'timeFrame': '12 months', 'description': 'Proportion of patients who experience cardiovascular irAEs during long-term follow-up, post-treatment'}, {'measure': 'Prevalence of cardiac irAEs', 'timeFrame': '12 months', 'description': 'Prevalence of cardiac irAEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melanoma', 'cardiac toxicity', 'immune related adverse events', 'immunotherapy treatment'], 'conditions': ['Melanoma Stage III or IV']}, 'descriptionModule': {'briefSummary': "People who develop a type of skin cancer known as 'melanoma' are often treated with immunotherapy. The type of immunotherapy used for patients with melanoma is known as Immune Checkpoint Inhibitors (ICI). While ICI is very successful, it can lead to negative side effects that are known as 'immune related adverse events' (irAEs). These irAEs can affect any part of the body and can range in severity from mild symptoms to death.\n\nThere has been a lot of research on irAEs that occur during ICI, but less is known about how irAEs can affect people in the long-term.\n\nAlthough irAEs are common from ICI, acute irAEs affecting the heart (cardiac irAEs) are uncommon. However, as they relate to the heart, they are often serious and have a higher rate of death compared to other types of irAEs. Little is known regarding the long-term effects of ICI on the heart. However, there is some evidence to suggest that ICI may also cause long-term cardiac irAEs such as accelerating a build-up of fatty materials in the arteries known as 'atherosclerosis' and inflammation of plaque in the heart. This can lead to an increased risk of heart attack.\n\nAlthough there are guidelines for patients on ICI treatment to receive investigations to look for irAEs, including cardiac irAEs, there are no guidelines for monitoring long-term survivors.\n\nThe aim of the CARD-IO study is to establish if it is possible to investigate in long-term follow-up cardiac side-effects in patients who received ICI for melanoma. The data for this study would be used to support a larger study in the same patient population. Potentially, this could lead to a change in guidelines and long-term follow-up care for melanoma patients who have received ICI.", 'detailedDescription': "Primary aim • To establish the feasibility of conducting a study to investigate late cardiac side effects caused by immunotherapy in patients with melanoma in order to generate data to support a larger study in this patient population.\n\nSecondary aims\n\n* To assess factors impacting on the acceptance and adherence with cardiac investigations.\n* To contribute to the understanding of long-term cardiac toxicities following immunotherapy which will enable their early recognition.\n\nPrimary endpoint\n\n• Acceptance rate (reported as the total number of patients consented divided by the number of patients invited for the study).\n\nSecondary endpoints\n\n* Adherence rate (reported as the proportion of patients completing all the scheduled cardiac screening tests divided by the number of patients enrolled in the study).\n* Recruitment rate (reported as the number of patients recruited on average per month in each site, and overall).\n* Reasons for non-adherence or declining to consent.\n* Difference in adherence rates between adjuvant early disease setting and metastatic setting.\n* Proportion of patients who experience cardiac irAEs during long-term follow-up, post-treatment.\n* Prevalence of cardiac irAEs.\n\nThe planned sample size is 60 participants.\n\nThe project will assess 3 groups of patients at different timepoints during their standard of care surveillance, at 2-4, 5-7 and 8-10 years following the completion of their immunotherapy treatment for melanoma. Patients on routine follow-up, at 2 to 10 years following the completion of immunotherapy treatment for melanoma will be identified by searching through database of patients with melanoma who received immune checkpoint inhibitors (ICI). Patients respecting the inclusion criteria will be invited to take to part to the study.\n\nPatients included in the study will undergo screening blood tests including cardiac biomarkers (troponin I, NTproBNP, lipid profile, HbA1c, ferritin), a 12 lead ECG and transthoracic echocardiography, a cardiac MRI alongside completing a questionnaire about cardiac events and risk factors. Patients will have blood tests done at Royal Marsden or Royal Free, while all the other cardiac investigations (ECG, transthoracic echocardiography, cardiac MRI) will be performed at the Royal Brompton Hospital. Surveillance imaging performed as per standard of care at the Royal Marsden or at the Royal Free will be reviewed for evidence of atherosclerosis by the team at the Royal Brompton. The cardiology team at the Royal Brompton will review cardiac investigations' results and abnormal results will be flagged.\n\nA summary report will be generated and sent to the patients, their GPs, and the Site irrespective of the results found, and abnormal results will be investigated as per standard of care. The prevalence of cardiac adverse events will be summarised."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from The Royal Marsden NHS Foundation Trust (RMH) and the Royal Free London NHS Trust (RFH) who are in follow up after receiving immunotherapy for melanoma 2-10+ years prior to enrolment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age 18 years or older\n* Confirmed diagnosis of melanoma\n* Stage IIB or IIC or stage III or stage IV melanoma\n* Previous immunotherapy with immune-checkpoint inhibitors (anti PD-(L)1 +/- anti CTLA-4) for melanoma\n* On standard of care surveillance, at 2 to 10+ years following the completion of immunotherapy treatment\n\nExclusion Criteria:\n\n* Medical or psychological condition that would preclude informed consent.\n* Known contraindications to MRI, such as claustrophobia, pregnancy, or indwelling metallic implant which is not MR conditional\n* Current active treatment with systemic therapy for any malignancy.\n* Active treatment with systemic therapy for any malignancy started after the completion of immunotherapy for melanoma.\n* Subjects unable to comply with the study or sample schedule.\n* Planned participation in a drug trial receiving investigational agents.'}, 'identificationModule': {'nctId': 'NCT06605833', 'acronym': 'CARD-IO', 'briefTitle': 'CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'CARD-IO - CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma', 'orgStudyIdInfo': {'id': 'CCR6063'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2-4 years', 'description': 'Patients on routine follow-up 2-4 years after the completion of immunotherapy treatment for melanoma', 'interventionNames': ['Diagnostic Test: 12-Lead ECG', 'Diagnostic Test: Transthoracic Echocardiogram', 'Diagnostic Test: Cardiac MRI', 'Diagnostic Test: Cardiac Biomarker Screening', 'Other: Basic Observations']}, {'label': '5-7', 'description': 'Patients on routine follow-up 5-7 years after the completion of immunotherapy treatment for melanoma', 'interventionNames': ['Diagnostic Test: 12-Lead ECG', 'Diagnostic Test: Transthoracic Echocardiogram', 'Diagnostic Test: Cardiac MRI', 'Diagnostic Test: Cardiac Biomarker Screening', 'Other: Basic Observations']}, {'label': '8-10+', 'description': 'Patients on routine follow-up 8-10+ years after the completion of immunotherapy treatment for melanoma', 'interventionNames': ['Diagnostic Test: 12-Lead ECG', 'Diagnostic Test: Transthoracic Echocardiogram', 'Diagnostic Test: Cardiac MRI', 'Diagnostic Test: Cardiac Biomarker Screening', 'Other: Basic Observations']}], 'interventions': [{'name': '12-Lead ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo a standard 12-lead ECG in order to record the electrical activity of the heart. This typically takes a few minutes and the ECG is read by a cardiologist\n\nThis is a Standard of Care test being performed at a non Standard of Care timepoint', 'armGroupLabels': ['2-4 years', '5-7', '8-10+']}, {'name': 'Transthoracic Echocardiogram', 'type': 'DIAGNOSTIC_TEST', 'description': "A transthoracic echocardiogram will be performed in accordance to standard British Society of Echocardiography guidelines. This will involve undertaking an ultrasound scan of the participant's heart with ultrasound jelly to obtain information including left ventricular function and valvular function.\n\nThis is a Standard of Care test being performed at a non Standard of Care timepoint", 'armGroupLabels': ['2-4 years', '5-7', '8-10+']}, {'name': 'Cardiac MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'A cardiac MRI scan will be performed in order to assess the morphology and function of the heart in accordance with international guidelines. Data that will be derived includes biventricular volumes and function and myocardial strain data.\n\nThis is a Standard of Care test being performed at a non Standard of Care timepoint', 'armGroupLabels': ['2-4 years', '5-7', '8-10+']}, {'name': 'Cardiac Biomarker Screening', 'type': 'DIAGNOSTIC_TEST', 'description': '* Cardiac Troponin I,\n* NTproBNP\\],\n* lipid profile,\n* HbA1c\n* ferritin\n\nThese are Standard of Care tests being performed at a non Standard of Care timepoint', 'armGroupLabels': ['2-4 years', '5-7', '8-10+']}, {'name': 'Basic Observations', 'type': 'OTHER', 'description': '* Heart rate\n* Blood pressure\n* Oxygen SAT\n* Respiratory rate\n\nThese are Standard of Care observations being performed at a non Standard of Care timepoint', 'armGroupLabels': ['2-4 years', '5-7', '8-10+']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW6 3JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a feasibility study to support the application of a larger more complex study by the same team on the same topic. Sharing of IPD would require additional consents and level of complexity in the Data Plan which current resource restraints does not allow. This will be considered for future studies based on this research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Free Hospital NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}