Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT05676866
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2023-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Node positive breast cancer patients post neo adjuvant therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients', 'timeFrame': '3 monthes'}, {'measure': 'Comparing sensetivity of targeted axillary dissection with traditional SLND', 'timeFrame': '3 monthes'}], 'secondaryOutcomes': [{'measure': 'Post operative complications: number of patients with arm lymphedema and sensory loss', 'timeFrame': '3 monthes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Node-positive Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015960/', 'label': 'The Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Initially Clinically Node-Negative Breast Cancer after Neoadjuvant Chemotherapy: A Systematic Review and Meta-Analysis'}, {'url': 'https://www.cureus.com/articles/44726-targeted-axillary-dissection-in-node-positive-breast-cancer-a-retrospective-study-and-cost-analysis', 'label': 'Targeted Axillary Dissection in Node-Positive Breast Cancer: A Retrospective Study and Cost Analysis'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5743998/', 'label': 'Improved Model for Predicting Axillary Response to Neoadjuvant Chemotherapy in Patients with Clinically Node-Positive Breast Cancer'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161347/', 'label': 'Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Clinically Node-Positive Breast Cancer after Neoadjuvant Chemotherapy: A Meta-Analysis'}, {'url': 'https://link.springer.com/article/10.1245/ASO.2005.09.007', 'label': 'Comprehensive Axillary Evaluation in Neoadjuvant Chemotherapy Patients With Ultrasonography and Sentinel Lymph Node Biopsy'}]}, 'descriptionModule': {'briefSummary': 'evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy', 'detailedDescription': 'Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).\n\nCompared to sentinel lymph node dissection (SLND), axillary lymph node dissection \\[ALND\\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.\n\nTargeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.\n\nBreast cancer patients suitable for neoadjuvant systemic therapy \\[NAST\\] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker\\[clip\\] is inserted in the suspicious node prior to neoadjuvant therapy.\n\nThe procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.\n\nA standard surgical approach for sentinel lymph node dissection \\[SLND\\] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Female patients with breast cancer and axillary metastasis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. females with invasive breast cancer with axillary metastasis, staging of n1: n2\n2. complete axillary response to neoadjuvant therapy by clinical examination and imaging\n\nExclusion Criteria:\n\n* 1\\. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour \\[not breast cancer\\]'}, 'identificationModule': {'nctId': 'NCT05676866', 'briefTitle': 'Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy', 'orgStudyIdInfo': {'id': 'Targeted axillary dissection'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast cancer patients with positive axillary nodes', 'description': 'Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response', 'interventionNames': ['Procedure: Targeted axillary lymph node dissection']}], 'interventions': [{'name': 'Targeted axillary lymph node dissection', 'type': 'PROCEDURE', 'description': 'Targeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection', 'armGroupLabels': ['Breast cancer patients with positive axillary nodes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Omar Abd. Mahmoud, Resident doc', 'role': 'CONTACT', 'email': 'omarico877@gmail.com', 'phone': '01098386293'}, {'name': 'Mohamed Ahmed Rizk, Demonstrator', 'role': 'CONTACT', 'email': 'med.rizk88@aun.edu.eg', 'phone': '+20 106 198 8555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor /Omar abdelnasser Mahmoud', 'investigatorFullName': 'Omar Abdelnasser Mahmoud Ali', 'investigatorAffiliation': 'Assiut University'}}}}