Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-06-26 @ 4:05 AM
Study NCT ID:
NCT02992067
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yuxf1177@zjcc.org.cn', 'phone': '057188122001', 'title': 'Yu Xingfei', 'phoneExt': '+86', 'organization': 'Zhejiang Cancer Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1year', 'eventGroups': [{'id': 'EG000', 'title': 'Operable Breast Cancer', 'description': 'clinical stage: cTis, cI, cII, cT3N1M0', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 0, 'seriousNumAtRisk': 359, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operable Breast Cancer', 'description': 'clinical stage: cTis, cI, cII, cT3N1M0'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0896', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination', 'unitOfMeasure': 'proportion of false negative lymphnodes', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Operable Breast Cancer', 'description': 'clinical stage: cTis, cI, cII, cT3N1M0'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Operable Breast Cancer', 'description': 'clinical stage: cTis, cI, cII, cT3N1M0'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.88', 'spread': '9.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '359', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '359', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lymph node involvement', 'classes': [{'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-02', 'size': 99157, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-11T19:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2016-12-09', 'resultsFirstSubmitDate': '2019-06-02', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-11', 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node', 'timeFrame': '1 year', 'description': 'The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lymph node metastasis', 'breast cancer', 'CK19', 'contrast-enhanced ultrasonography'], 'conditions': ['Lymph Node', 'Breastcancer']}, 'referencesModule': {'references': [{'pmid': '31659631', 'type': 'DERIVED', 'citation': 'Qiao E, Yu X, Zhou L, Wang C, Yang C, Yu Y, Chen D, Huang J, Yang H. A Prospective Validation Cohort Study of a Prediction Model on Non-sentinel Lymph Node Involvement in Early Breast Cancer. Ann Surg Oncol. 2020 May;27(5):1653-1658. doi: 10.1245/s10434-019-07980-x. Epub 2019 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.', 'detailedDescription': 'The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of specimen bank; to establish the evaluation system of predicting the lymph node status based on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive predictive value and ROC curve of the system model and use Youden index, negative likelihood ratio, positive likelihood ratio to evaluate the diagnostic efficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Operable breast cancer patients (clinical stage: cTis, cI, cII, cT3N1M0)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female, age 18\\~70 years old\n2. the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample\n\nExclusion criteria:\n\n1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging\n2. pregnancy or lactation\n3. patients with hematopoietic system disease or cancer, autoimmune diseases\n4. preservation of substandard peripheral blood samples.'}, 'identificationModule': {'nctId': 'NCT02992067', 'acronym': 'CK-CEUS', 'briefTitle': 'CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer', 'orgStudyIdInfo': {'id': 'ZJCH-CK19A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operable breast cancer', 'description': 'clinical stage: cTis, cI, cII, cT3N1M0'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xingfei Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Breast Tumor Surgery (Department 104)', 'investigatorFullName': 'YU Xingfei', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}