Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer (GATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293865
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: sentinel node Procedure: GAS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Study Start Date : March 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: sentinel node
    detection of the sentinel node in breast cancer
    Procedure: GAS

Primary Outcome Measures :
  1. false negatives

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Previous conservative surgical biopsy
  • Secondary pathological diagnosis of infiltrative cancer
  • No clinically involved axillary node (N0)
  • No previous neoadjuvant treatment
  • Performance status European Cancer Conference (ECCO) Grade ≤ 1
  • Patient's written informed consent to participate in the study according to French law
  • Surgeon must have performed its learning curve

Exclusion Criteria:

  • Lack of infiltrative breast carcinoma (in situ) pT4d > N0
  • Breast cancer relapse
  • Pregnancy
  • Known patent blue allergy
  • Indication for radical or partial mastectomy
  • Patient unable to understand the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293865

Angers, France, 49000
Institut Bergonié
Bordeaux, France, 33076
Brest, France, 29000
Centre Hospitalier
La roche sur yon, France, 85000
Centre Oscar Lambret
Lille, France, 59020
centre Léon Berard
Lyon, France, 69000
Institut Paoli Calmette
Marseille, France, 13273
Centre Alexis Vautrin
Nancy, France, 54000
Nancy, France, 54511
Hopital Lariboisière
Paris, France, 75 000
Hopital Européen Georges Pompidou
Paris, France, 75000
Hôpital Tenon
Paris, France, 75970
Poitiers, France, 86000
Institut Jean Godinot
Reims, France, 51056
Centre Eugène Marquis
Rennes, France, 35062
Centre René Gauducheau
Saint Herblain, France, 44805
Centre Claudius Regaud
Toulouse, France, 31052
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Principal Investigator: Jean Marc Classe, MD Centre Rene Gauducheau

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Institut Cancerologie de l'Ouest Identifier: NCT00293865     History of Changes
Other Study ID Numbers: BRD 05/11-M
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Institut Cancerologie de l'Ouest:
Breast infiltrative cancer

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