Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-24 @ 3:32 PM
Study NCT ID:
NCT02440620
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Toxicity in Medical Treatment of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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_WITH_DNA', 'description': 'Blood samples will be analyzed for N-terminal proBNP and ultra-sensitive TnT. Targeted sequencing of a limited number of well-known genes related to heart failure will be conducted and analysis of potential future biomarkers related to heart failure is possible from blood samples stored in a biobank.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global longitudinal strain by two dimentional speckle tracking.', 'timeFrame': 'Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.'}, {'measure': 'Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).', 'timeFrame': 'Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart failure related to medical treatment of breast cancer'], 'conditions': ['Heart Failure', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.\n\nIn a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HER2 positive breast cancer in adjuvant treatment with trastuzumab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HER2 positive breast cancer\n* Adjuvant treatment with trastuzumab\n\nExclusion Criteria:\n\n* Left ventricle ejection fraction (LVEF) \\<50%\n* Chronic or persistent atrial fibrillation\n* History of moderate or severe valvular heart disease.'}, 'identificationModule': {'nctId': 'NCT02440620', 'acronym': 'CaTOB', 'briefTitle': 'Cardiac Toxicity in Medical Treatment of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Cardiac Toxicity in Medical Treatment of Breast Cancer', 'orgStudyIdInfo': {'id': 'S-20140090'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Jacob Moeller, MD, DMsc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.d.-student', 'investigatorFullName': 'Ann Banke', 'investigatorAffiliation': 'Odense University Hospital'}}}}