Sentinel Lymph Node Technique in Multifocal Breast Cancer
NCT ID: NCT00417495
Last Updated: 2016-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2006-03-31
2008-09-30
Brief Summary
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Detailed Description
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* association of subareolar injection of technecium and blue dye
* or, in case of blue dye allergy, by the subareolar injection of technecium only
* 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
* This procedure is immediately follows by complete axillary dissection during breast surgery
* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Sentinel Lymph Node Technique
Eligibility Criteria
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Inclusion Criteria
* At least 2 focuses (clinically and/or by mammography or ultrasound)
* Proven by pre-surgical histology (on 1 focus at least)
* Age \> 18 years old
* Clinically negative axillary lymph nodes
* No treatment before surgery
* Signature of written informed consent
Exclusion Criteria
* Non invasive breast cancer
* Inflammatory breast cancer
* Axillary lymph node
* Metastatic disease
* Previous homolateral breast cancer
* Dementia or alterated mental status
* Pregnant or lactating woman
18 Years
FEMALE
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Centre Oscar Lambret - LILLE (France)
Principal Investigators
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GIARD Sylvia, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Hospitalier Universitaire
Amiens, , France
Centre Paul Papin
Angers, , France
Institut Bergonie
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Clinique de Flandre
Coudekerque-Branche, , France
Centre Georges-Francois LECLERCQ
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CRLC Val d'Aurelle
Montpellier, , France
Hôpital Lariboisière
Paris, , France
Hopital Tenon
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Gauducheau
Saint-Herblain, , France
Centre Hospitalier Sud Léman Valsérine
Saint-Julien-en-Genevois, , France
Hôpital Georges PIANTA
Thonon-les-Bains, , France
Centre Claudius Regaud
Toulouse, , France
Centre Hospitalier
Valenciennes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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IGASSU 0502
Identifier Type: -
Identifier Source: org_study_id
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