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

April 18, 2016 updated by: Institut Cancerologie de l'Ouest

Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

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
      • Angers, France, 49000
        • Hospital
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Brest, France, 29000
        • Hospital
      • La roche sur yon, France, 85000
        • Centre Hospitalier
      • Lille, France, 59020
        • Centre OSCAR LAMBRET
      • Lyon, France, 69000
        • Centre LEON BERARD
      • Marseille, France, 13273
        • Institut Paoli Calmette
      • Nancy, France, 54000
        • Centre Alexis Vautrin
      • Nancy, France, 54511
        • Hospital
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75000
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75 000
        • Hôpital Lariboisière
      • Poitiers, France, 86000
        • Hospital
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35062
        • Centre Eugene Marquis
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau
      • Toulouse, France, 31052
        • Centre Claudius Régaud

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

Genders Eligible for Study

Female

Description

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

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
false negatives

Collaborators and Investigators

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

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Jean Marc Classe, MD, Centre Rene Gauducheau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 05/11-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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