Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03857932
Status:
RECRUITING
Last Update Posted:
2021-08-31
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'Up to 10 years', 'description': 'Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 10 years', 'description': 'Time from randomization to death from any cause, assessed up to 10 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.', 'detailedDescription': 'AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.\n\nArm1：\n\n1. Participants received preoperative computed tomographic lymphography\n2. Participants received sentinel lymph node biopsy（SLNB）\n3. Participants received stained non-sentinel lymph node resection during SLNB\n4. Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy\n2. abnormal para-sentinel lymph node was found by ultrasound examination\n3. ultrasound-guided fine needle aspiration cytology of these nodes were performed\n4. the result of fine needle aspiration cytology was negative (no tumour cell was found)\n5. participants planed to perform SLNB\n\nExclusion Criteria:\n\n1. pathological diagnosed ductal carcinoma in situ by excisional biopsy\n2. the result of fine needle aspiration cytology was positive\n3. participants has received neo-adjuvant system therapy'}, 'identificationModule': {'nctId': 'NCT03857932', 'briefTitle': 'Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer', 'orgStudyIdInfo': {'id': 'HECT004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLNB and non-slns resection', 'description': '1. Participants only receive SLNB\n2. preoperative CT lymphography\n3. SLNB with stained non-SLN resection\n4. SLNB with ARM dissection', 'interventionNames': ['Procedure: Participants receive SLNB as well as non SLNs resection']}, {'type': 'EXPERIMENTAL', 'label': 'SLNB group', 'description': 'Participants only receive SLNB', 'interventionNames': ['Procedure: Participants receive SLNB as well as non SLNs resection']}], 'interventions': [{'name': 'Participants receive SLNB as well as non SLNs resection', 'type': 'PROCEDURE', 'description': 'Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection', 'armGroupLabels': ['SLNB and non-slns resection', 'SLNB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qifeng Yang', 'role': 'CONTACT', 'phone': '+8618560085168'}, {'name': 'Xiaoyan Li', 'role': 'CONTACT', 'email': 'wdjlc108822@163.com', 'phone': '+8618560080551'}], 'facility': 'Qifeng Yang', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Qifeng Yang', 'role': 'CONTACT', 'email': 'qifengy_sdu@163.com', 'phone': '+8618560085168'}, {'name': 'Xiaoyan Li', 'role': 'CONTACT', 'email': 'wdjlc108822@163.com', 'phone': '+8618560080551'}], 'overallOfficials': [{'name': 'Qifeng Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifeng Yang', 'investigatorAffiliation': 'Shandong University'}}}}