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Sentinel Lymph Node Technique in Multifocal Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00417495
First received: December 29, 2006
Last updated: May 22, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Behavioral: Sentinel Lymph Node Technique
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • detection rate of sentinel nodes [ Time Frame: surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of sentinel nodes removed [ Time Frame: surgery ] [ Designated as safety issue: No ]
  • localisation of the sentinel nodes [ Time Frame: surgery ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417495

Locations
France
Centre Hospitalier Universitaire
Amiens, France, 80054
Centre Paul Papin
Angers, France, 49933
Institut Bergonie
Bordeaux, France, 33076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Clinique de Flandre
Coudekerque Branche, France, 59210
Centre Georges-Francois LECLERCQ
Dijon, France, 21000
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 130009
CRLC Val d'Aurelle
Montpellier, France, 34298
Hôpital Lariboisière
Paris, France, 75010
Hopital Tenon
Paris, France, 75970
Centre Eugene Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
Centre Hospitalier Sud Léman Valsérine
SAINT JULIEN en GENEVOIS, France, 74167
Centre Rene Gauducheau
Saint-Herblain, France, 44805
Hôpital Georges PIANTA
THONON-les-BAINS, France, 74203
Centre Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier
Valenciennes, France, 59300
Institut Gustave Roussy
Villejuif, France, 94808
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: GIARD Sylvia, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Sylvia GIARD, MD, PhD, Centre Oscar Lambret - LILLE (France)
ClinicalTrials.gov Identifier: NCT00417495     History of Changes
Other Study ID Numbers: 2005-02
Study First Received: December 29, 2006
Last Updated: May 22, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
adenocarcinoma, breast, multifocal lesions, surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013