Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 1:21 AM
Study NCT ID:
NCT04541212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial extracellular volume (ECV)', 'timeFrame': 'Change from baseline to 3, 6, 12,and 24 months', 'description': 'Cohort A'}, {'measure': 'Myocardial extracellular volume (ECV)', 'timeFrame': 'Change from baseline to prior study entry, 12 and 24 months post study entry.', 'description': 'Cohort B'}], 'secondaryOutcomes': [{'measure': 'Left ventricular (LV) systolic function (global and regional)', 'timeFrame': 'Change from baseline to 3, 6, 12,and 24 months.', 'description': 'Cohort A'}, {'measure': 'Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))', 'timeFrame': 'Change from baseline to 3, 6, 12,and 24 months.', 'description': 'Cohort A'}, {'measure': 'Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))', 'timeFrame': 'Change from baseline to 3, 6, 12,and 24 months.', 'description': 'Cohort A'}, {'measure': 'Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))', 'timeFrame': 'Change from baseline to 3, 6, 12,and 24 months.', 'description': 'Cohort A'}, {'measure': 'Clonal hematopoiesis associated gene mutations.', 'timeFrame': 'Change from baseline to 24 months..', 'description': 'Cohort A'}, {'measure': 'Telomere length measurement', 'timeFrame': 'Change from baseline to 24 months..', 'description': 'Cohort A'}, {'measure': 'Left ventricular (LV) systolic function (global and regional)', 'timeFrame': 'Change from study entry to 12 and 24 months.', 'description': 'Cohort B'}, {'measure': 'Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))', 'timeFrame': 'Change from study entry to 12 and 24 months.', 'description': 'Cohort B'}, {'measure': 'Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))', 'timeFrame': 'Change from study entry to 12 and 24 months.', 'description': 'Cohort B'}, {'measure': 'Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))', 'timeFrame': 'Change from study entry to 12 and 24 months.', 'description': 'Cohort B'}, {'measure': 'Clonal hematopoiesis associated gene mutations.', 'timeFrame': 'Change from baseline to 24 months..', 'description': 'Cohort B'}, {'measure': 'Telomere length measurement', 'timeFrame': 'Change from baseline to 24 months..', 'description': 'Cohort B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Lymphoma', 'Leukemia']}, 'descriptionModule': {'briefSummary': 'This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations.\n\nSafety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.', 'detailedDescription': 'The aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (Cohort A: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (Cohort B: retrospective and prospective evaluations). Part A and B will be conducted in parallel. This study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '225 patients enrolled from oncology clinics. Patients will be screened and identified at the oncology clinics. The prospective cardiac evaluations including New York Heart Association (NYHA) functional classification, transthoracic echocardiography, CMR, standard 12-lead electrocardiogram (ECG), cardiac biomarkers, lipid profile \\& HDL functionality tests will be performed at the Montreal Heart Institute (MHI).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older at time of CT initiation\n* Signed informed consent\n* Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects)\n* Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline\n* Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy\n* The participant is willing to undergo CMR scans and all other required study procedures\n\nExclusion Criteria:\n\n* Known cardiomyopathy and/or LVEF \\<50%\n* Known heart failure\n* History of myocardial infarction (MI)\n* Clinically significant cardiac valvular disease\n* Clinically significant pericardial effusion\n* Allografted subjects\n* Contraindications to CMR testing (Cohort A \\& prospective evaluation for Cohort B):\n\n * Pacemakers, other metallic implants or severe claustrophobia\n * Weight \\> 135 kg\n * Patients with a history of previous allergic reaction to gadolinium\n * Patients with history of seizure\n * Renal insufficiency (eGFR of \\< 45ml/min/1.73m2 using the MDRD equation)\n * Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04541212', 'acronym': 'CarChem', 'briefTitle': 'Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia', 'orgStudyIdInfo': {'id': 'MHICC-2018-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Prospective', 'interventionNames': ['Diagnostic Test: Cardiac Imaging']}, {'label': 'Cohort B', 'description': 'Retrospective/Prospective', 'interventionNames': ['Diagnostic Test: Cardiac Imaging', 'Other: Data Collection']}], 'interventions': [{'name': 'Cardiac Imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Blood tests'], 'description': 'Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test', 'armGroupLabels': ['Cohort A', 'Cohort B']}, {'name': 'Data Collection', 'type': 'OTHER', 'description': 'Collection of retrospective data', 'armGroupLabels': ['Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X0C1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1M5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J6V 2H2', 'city': 'Terrebonne', 'state': 'Quebec (QC)', 'country': 'Canada', 'facility': 'CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site)', 'geoPoint': {'lat': 45.70004, 'lon': -73.64732}}], 'overallOfficials': [{'name': 'Jean-Claude Tardif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}