Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
Study NCT ID:
NCT04535466
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-08-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'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': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the predictive model's area under curve(AUC)", 'timeFrame': 'follow up for 2 year for individuals', 'description': 'To assess the predictive accuracy of the radiomic-based and clinical-based model by using operating characteristic curve (ROC) analysis and calculating the area under the curves (AUC).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Diseases', 'Artificial Intelligence', 'Dense Breast Density', 'Predictive Cancer Model']}, 'descriptionModule': {'briefSummary': 'It is a prospective, observational cohort study of patients with dense breast tissue. The study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast disease by using artificial intelligence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients aged 18-80 were included in our study who were diagnosed and treated at Sun Yat-sen memorial hospital .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with dense breast density tissue\n* Digital breast tomosynthesis was performed\n* Breast ultrasound examination was performed\n* Pathologic examination of breast lesions was performed\n\nExclusion Criteria:\n\n* Incomplete clinicopathologic data\n* Female patients with fatty glands of the breast'}, 'identificationModule': {'nctId': 'NCT04535466', 'briefTitle': 'Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Development of an Artificial Intelligence Precise Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics', 'orgStudyIdInfo': {'id': 'SYSU_AI01'}}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yaping yang, Doctor', 'role': 'CONTACT', 'email': 'yangyap2@mail.sysu.edu.cn', 'phone': '0086-020-34071145'}, {'name': 'Herui Yao, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chang Gong, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yunfang Yu, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yue Hu, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ran Gu, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Junwei Li, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Breast tumor center of Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yaping Yang, Doctor', 'role': 'CONTACT', 'email': 'yangyap2@mail.sysu.edu.cn', 'phone': '86020-34071145'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yaping yang', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}