Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01146158
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2010-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Axillary Reverse Mapping for Breast Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of the principal objectives is qualified as finding one or more radioactive node in zone D', 'timeFrame': '1 day', 'description': 'Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein.\n\nIf all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective'}], 'secondaryOutcomes': [{'measure': 'Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node', 'timeFrame': '15 days', 'description': 'Evaluate the incidence of metastatic or micro-metastatic disease within'}, {'measure': 'Evaluate the correlation between clinical and histological results', 'timeFrame': '15 days', 'description': 'Evaluate the correlation between clinical and histological results'}, {'measure': 'Evaluate the morbidity associated with Axillary Dissection.', 'timeFrame': '1 year, 2 years and 5 years', 'description': 'Evaluate the morbidity associated with Axillary Dissection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Axillary dissection'], 'conditions': ['Axillary Dissection']}, 'referencesModule': {'references': [{'pmid': '17549570', 'type': 'BACKGROUND', 'citation': 'Nos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. doi: 10.1245/s10434-007-9450-4. Epub 2007 Jun 5.'}, {'pmid': '18618185', 'type': 'BACKGROUND', 'citation': 'Nos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.', 'detailedDescription': 'Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for formal Axillary Dissection (AD)\n* N0 patient with a large tumor: T3\n* N1 patient\n* N2 patient with axillary imaging showing limited node involvement(1-4N+).\n* Secondary AD after a positive sentinel node ( pN1, pN1(mi))\n* AD after préopérative chemotherapy in a patient initially N+.\n* Age between 18 and 70\n* Signature of the consent form.\n* Patients beneficiary of the Social Security\n\nExclusion Criteria:\n\n* N0 patient with an indication of Sentinel Node biopsy\n* N2 patient with axillary imaging showing suspected node involvement \\>4N+.\n* N3 patient\n* Age over 70\n* Pregnancy\n* Blue dye allergy\n* Mentally deficient patient'}, 'identificationModule': {'nctId': 'NCT01146158', 'acronym': 'SENTIBRAS', 'briefTitle': 'Axillary Reverse Mapping for Breast Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.', 'orgStudyIdInfo': {'id': 'P070154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery Axillary dissection', 'description': 'surgery Axillary dissection', 'interventionNames': ['Procedure: Axillary dissection for breast carcinomas']}], 'interventions': [{'name': 'Axillary dissection for breast carcinomas', 'type': 'PROCEDURE', 'otherNames': ['surgery Axillary dissection'], 'description': 'surgery Axillary dissection', 'armGroupLabels': ['surgery Axillary dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital European Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Claude NOS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}