Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
Study NCT ID:
NCT03355261
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2017-11-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location', 'timeFrame': 'During the surgery', 'description': 'After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive.'}], 'secondaryOutcomes': [{'measure': 'The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location', 'timeFrame': 'During the surgery', 'description': 'If the chemotherapy is sensitive, the number of black-stained nodes will increase from Level I, Level II, to Level III. If the chemotherapy is resistance, the number of black-stained nodes will remain the original number or a little increasing locally.'}, {'measure': 'The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location', 'timeFrame': 'During the surgery', 'description': 'After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from above ICBN to below ICBN. This means that if the nodes below ICBN are negative, the nodes above ICBN will be negative; if the nodes above ICBN are positive, the nodes below ICBN will be positive.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33926797', 'type': 'DERIVED', 'citation': 'Li J, Jia S, Wang Y, Zhang Y, Kong L, Cao Y, Liu Y, Zhang Y, Chen B. Long-term tracing and staining of carbon nanoparticles for axillary lymph nodes in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy. Asian J Surg. 2022 Jan;45(1):89-96. doi: 10.1016/j.asjsur.2021.03.020. Epub 2021 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.', 'detailedDescription': 'Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive ductal carcinoma diagnosed by biopsy;\n* clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;\n* NAC regimen followed the NCCN guideline;\n* no prior history of breast cancer or other malignancies.\n\nExclusion Criteria:\n\n* the cycle number of neo-adjuvant chemotherapy is equal to or less than 2'}, 'identificationModule': {'nctId': 'NCT03355261', 'briefTitle': 'Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'ShengjingH01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'complete remission (CR) group', 'description': 'According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).', 'interventionNames': ['Procedure: complete remission (CR) group']}, {'type': 'EXPERIMENTAL', 'label': 'partial remission (PR) group', 'description': 'According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).', 'interventionNames': ['Procedure: partial remission (PR) group']}, {'type': 'EXPERIMENTAL', 'label': 'stable disease (SD) group', 'description': 'According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).', 'interventionNames': ['Procedure: stable disease (SD) group']}, {'type': 'EXPERIMENTAL', 'label': 'progressive disease (PD) group', 'description': 'According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).', 'interventionNames': ['Procedure: progressive disease (PD) group']}], 'interventions': [{'name': 'complete remission (CR) group', 'type': 'PROCEDURE', 'description': 'According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).', 'armGroupLabels': ['complete remission (CR) group']}, {'name': 'partial remission (PR) group', 'type': 'PROCEDURE', 'description': 'According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).', 'armGroupLabels': ['partial remission (PR) group']}, {'name': 'stable disease (SD) group', 'type': 'PROCEDURE', 'description': 'According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).', 'armGroupLabels': ['stable disease (SD) group']}, {'name': 'progressive disease (PD) group', 'type': 'PROCEDURE', 'description': 'According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).', 'armGroupLabels': ['progressive disease (PD) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Jianyi Li, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jianyi Li', 'investigatorAffiliation': 'Shengjing Hospital'}}}}