Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-02 @ 4:54 PM
Study NCT ID:
NCT00417495
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2006-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Lymph Node Technique in Multifocal Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2006-12-29', 'studyFirstSubmitQcDate': '2006-12-29', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection rate of sentinel nodes', 'timeFrame': 'surgery'}], 'secondaryOutcomes': [{'measure': 'number of sentinel nodes removed', 'timeFrame': 'surgery'}, {'measure': 'localisation of the sentinel nodes', 'timeFrame': 'surgery'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma, breast, multifocal lesions, surgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer', 'detailedDescription': 'The sentinel lymph node is located preferentially by:\n\n* association of subareolar injection of technecium and blue dye\n* or, in case of blue dye allergy, by the subareolar injection of technecium only\n* or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery\n* This procedure is immediately follows by complete axillary dissection during breast surgery\n* The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multifocal invasive breast cancer\n* At least 2 focuses (clinically and/or by mammography or ultrasound)\n* Proven by pre-surgical histology (on 1 focus at least)\n* Age \\> 18 years old\n* Clinically negative axillary lymph nodes\n* No treatment before surgery\n* Signature of written informed consent\n\nExclusion Criteria:\n\n* Multifocality proven after surgery\n* Non invasive breast cancer\n* Inflammatory breast cancer\n* Axillary lymph node\n* Metastatic disease\n* Previous homolateral breast cancer\n* Dementia or alterated mental status\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT00417495', 'briefTitle': 'Sentinel Lymph Node Technique in Multifocal Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502', 'orgStudyIdInfo': {'id': 'IGASSU 0502'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sentinel Lymph Node Technique', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59210', 'city': 'Coudekerque-Branche', 'country': 'France', 'facility': 'Clinique de Flandre', 'geoPoint': {'lat': 51.02288, 'lon': 2.39359}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges-Francois LECLERCQ', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '130009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre Rene Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '74167', 'city': 'Saint-Julien-en-Genevois', 'country': 'France', 'facility': 'Centre Hospitalier Sud Léman Valsérine', 'geoPoint': {'lat': 46.14434, 'lon': 6.08256}}, {'zip': '74203', 'city': 'Thonon-les-Bains', 'country': 'France', 'facility': 'Hôpital Georges PIANTA', 'geoPoint': {'lat': 46.37049, 'lon': 6.47985}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '94808', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'GIARD Sylvia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sylvia GIARD, MD, PhD', 'oldOrganization': 'Centre Oscar Lambret - LILLE (France)'}}}}