Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05358093
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy', 'timeFrame': 'baseline', 'description': 'detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://seer.cancer.gov/csr/1975_2012/', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/12165639', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .\n\nSimilarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .\n\nPost-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .\n\nCardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.\n\nRadiotherapy also have cardio toxic effect through different mechanisms'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female with left breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2\n\nExclusion Criteria:\n\n* • Patient \\> 75 years old\n\n * Non histological diagnosed\n * Metastatic patient\n * Patient with cardiac or other co morbidity.\n * ECoG performance status \\>2\n * pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT05358093', 'briefTitle': 'Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer', 'orgStudyIdInfo': {'id': 'left breast cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': '45'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira Hussien Ahmed, master', 'role': 'CONTACT', 'email': 'hussienamira57@gmail.com', 'phone': '01018719085'}, {'name': 'amira hussien, master degree', 'role': 'CONTACT', 'email': 'hussienamira57@gmail.com', 'phone': '01018719085'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Amira Hussien Ahmed Hussien', 'investigatorAffiliation': 'Assiut University'}}}}