Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 12:15 PM
Study NCT ID:
NCT04483804
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Radiomics in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metastasis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'lymph node metastasis and/or distant metastasis'}, {'measure': 'death', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Ultrasound', 'Elastography', 'Pathology', 'Radiomics']}, 'descriptionModule': {'briefSummary': 'Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with breast cancer', 'genderDescription': 'Female dominated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of breast cancer\n\nExclusion Criteria:\n\nMissing pathology Missing follow-up results Missing data'}, 'identificationModule': {'nctId': 'NCT04483804', 'briefTitle': 'Application of Radiomics in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer', 'orgStudyIdInfo': {'id': 'SAHZhejiangU---Breast'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'disease free survival', 'description': 'Time from randomization to relapse or death due to disease progression', 'interventionNames': ['Combination Product: Endocrine therapy']}, {'label': 'non-disease free survival', 'description': 'Time of metastasis or death', 'interventionNames': ['Combination Product: Endocrine therapy']}], 'interventions': [{'name': 'Endocrine therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Endocrine therapy', 'armGroupLabels': ['disease free survival', 'non-disease free survival']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zimei Lin', 'role': 'CONTACT', 'email': 'zimei.lin@zju.edu.cn', 'phone': '+86151517171799'}, {'name': 'jifan Chen', 'role': 'CONTACT', 'email': 'jifanchen@zju.edu.cn', 'phone': '+8613605771565'}], 'facility': 'the Second Affiliated Hospital Zhejiang University School of Medicine'}], 'centralContacts': [{'name': 'zimei Lin', 'role': 'CONTACT', 'email': 'zimei.lin@zju.edu.cn', 'phone': '+8615157171799'}, {'name': 'jifan Chen', 'role': 'CONTACT', 'email': 'jifanchen@zju.edu.cn', 'phone': '+8613605771565'}], 'overallOfficials': [{'name': 'pintong Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'by request', 'ipdSharing': 'YES', 'description': 'individual participant data (IPD) can be shared after the main unit publish articles', 'accessCriteria': 'by request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}