Sentinel Lymph Node Technique in Multifocal Breast Cancer

NCT ID: NCT00417495

Last Updated: 2016-01-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-09-30

Brief Summary

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The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Detailed Description

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The sentinel lymph node is located preferentially by:

* 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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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Sentinel Lymph Node Technique

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Multifocal invasive breast cancer
* 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

* Multifocality proven after surgery
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

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

Site Status

Centre Paul Papin

Angers, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Clinique de Flandre

Coudekerque-Branche, , France

Site Status

Centre Georges-Francois LECLERCQ

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

CRLC Val d'Aurelle

Montpellier, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre Rene Gauducheau

Saint-Herblain, , France

Site Status

Centre Hospitalier Sud Léman Valsérine

Saint-Julien-en-Genevois, , France

Site Status

Hôpital Georges PIANTA

Thonon-les-Bains, , France

Site Status

Centre Claudius Regaud

Toulouse, , France

Site Status

Centre Hospitalier

Valenciennes, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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IGASSU 0502

Identifier Type: -

Identifier Source: org_study_id

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