Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT03155802
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Biomarkers and Echocardiography for Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001943', 'term': 'Breast 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'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum will be kept at -70 degrees of Celsius for future research'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between modifications in chemotherapy with detection of subclinical cardiotoxicity', 'timeFrame': 'up to 10 weeks', 'description': 'frequency of chemotherapy changes with subclinical cardiotoxicity'}], 'primaryOutcomes': [{'measure': 'Association of Heart Failure Biomarkers with Global Longitudinal strain rate', 'timeFrame': 'up to 35 weeks', 'description': 'N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate'}], 'secondaryOutcomes': [{'measure': 'Prediction of initiation/change in cardiovascular medications based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'NT-proBNP'}, {'measure': 'Prediction of initiation/change in cardiovascular medications based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'ST2'}, {'measure': 'Prediction of initiation/change in cardiovascular medications based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'hs-troponin'}, {'measure': 'Prediction of initiation/change in cardiovascular medications based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'galectin-3'}, {'measure': 'Prediction of cardiotoxicity based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'galectin-3'}, {'measure': 'Prediction of cardiotoxicity based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'NT-proBNP'}, {'measure': 'Prediction of cardiotoxicity based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'hs-troponin'}, {'measure': 'Prediction of cardiotoxicity based on serum biomarkers', 'timeFrame': 'up to 35 weeks', 'description': 'ST2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiotoxicity', 'Heart Failure', 'Breast Cancer', 'Anthracycline Induced Cardiomyopathy', 'Biomarkers', 'Echocardiography']}, 'descriptionModule': {'briefSummary': 'This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.', 'detailedDescription': 'Anthracyclines and other chemotherapy agents are associated with cardiotoxicity. The risk of cardiac related toxicity is increased in patients with advanced age, with multiple comorbid conditions, and those needing prolonged or intensive treatment. These patients require a tailored approach to surveillance, early diagnosis and treatment of cardiac issues related to cancer therapy, with timely decision making with respect to alterations in therapy. A serum biomarker approach alone or in combination with imaging indices holds promise for early identification, risk stratification and monitoring of chemotherapy related cardiotoxicity.\n\nThirty-five consecutive adult females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab) will be enrolled.\n\nA detailed medical history (interim where appropriate), physical exam, collection of blood samples for the measurement of Heart Failure (HF) biomarkers (and standard chemistry and hematology parameters), electrocardiogram and a 2D/3D echo cardiogram including the measurement of global longitudinal strain will be performed at baseline, mid chemotherapy, at the end of chemotherapy and 6 months post the completion of chemotherapy. (echocardiogram will not be done during chemotherapy).\n\nThe hypothesis being tested in this prospective trial is whether early changes in the levels of serum biomarkers of stress (N terminal pro B-type natriuretic peptide (NT-proBNP)), inflammation (ST2), necrosis (hs troponin), and fibrosis (galectin-3) will correlate with changes in sub-clinical left ventricular dysfunction as assessed by 3-dimensional (3D) echocardiogram with speckle tracking/strain in breast cancer patients receiving anthracycline based chemotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female subjects aged 18-85 years old\n2. Biopsy-proven diagnosis of invasive breast cancer carcinoma\n3. Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)\n\nExclusion Criteria:\n\n1. History of major heart disease at the time of breast cancer diagnosis (myocardial infarction or known left ventricular dysfunction (LVD) at baseline (defined as ejection fraction \\<40%)\n2. History of known obstructive coronary artery disease (CAD), or coronary revascularization within the past 1 year\n3. History of clinical heart failure or previous heart failure hospitalization\n4. Patients with elevations in NT-pro BNP (above 3x ULN), or ST2 (above 2x ULN), galectin-3 (above 2x ULN), or hs troponin (above 2x ULN) during baseline screening\n5. Patients with metastatic disease or recurrent breast cancer at diagnosis\n6. History of other chemotherapy treated malignancy'}, 'identificationModule': {'nctId': 'NCT03155802', 'briefTitle': 'Novel Biomarkers and Echocardiography for Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines', 'orgStudyIdInfo': {'id': '922042'}}, 'contactsLocationsModule': {'locations': [{'zip': '11738', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Bloom, MD', 'role': 'CONTACT', 'email': 'michelle.bloom@stonybrookmedicine.edu', 'phone': '631-444-2031'}], 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'centralContacts': [{'name': 'Michelle Bloom, MD', 'role': 'CONTACT', 'email': 'michelle.bloom@stonybrookmedicine.edu', 'phone': '6314442031'}, {'name': 'Indre Caikauskaite', 'role': 'CONTACT', 'email': 'indre.caikauskaite@stonybrookmedicine.edu', 'phone': '6314442031'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}