Sentinel Lymph Node Technique in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Behavioral: Sentinel Lymph Node Technique

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Amiens, France, 80054
    - Centre Hospitalier Universitaire
  - Angers, France, 49933
    - Centre Paul Papin
  - Bordeaux, France, 33076
    - Institut Bergonie
  - Clermont-Ferrand, France, 63011
    - Centre Jean Perrin
  - Coudekerque-Branche, France, 59210
    - Clinique de Flandre
  - Dijon, France, 21000
    - Centre Georges-Francois LECLERCQ
  - Lille, France, 59020
    - Centre Oscar Lambret
  - Lyon, France, 69373
    - Centre Leon Berard
  - Marseille, France, 130009
    - Institut Paoli Calmettes
  - Montpellier, France, 34298
    - CRLC Val d'Aurelle
  - Paris, France, 75970
    - Hopital Tenon
  - Paris, France, 75010
    - Hôpital Lariboisiere
  - Rennes, France, 35042
    - Centre Eugene Marquis
  - Rouen, France, 76038
    - Centre Henri Becquerel
  - Saint-Herblain, France, 44805
    - Centre René Gauducheau
  - Saint-Julien-en-Genevois, France, 74167
    - Centre Hospitalier Sud Léman Valsérine
  - Thonon-les-Bains, France, 74203
    - Hôpital Georges PIANTA
  - Toulouse, France, 31052
    - Centre Claudius Régaud
  - Valenciennes, France, 59300
    - Centre hospitalier
  - Villejuif, France, 94808
    - Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection rate of sentinel nodes Time Frame: surgery	surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
number of sentinel nodes removed Time Frame: surgery	surgery
localisation of the sentinel nodes Time Frame: surgery	surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

Principal Investigator: GIARD Sylvia, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2006

Primary Completion (Actual)

August 13, 2010

Study Completion (Actual)

August 13, 2010

Study Registration Dates

First Submitted

December 29, 2006

First Submitted That Met QC Criteria