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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT00293865
First received: February 17, 2006
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
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 Intervention
Breast Cancer
Procedure: sentinel node
Procedure: GAS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • false negatives

Enrollment: 203
Study Start Date: March 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: sentinel node
    detection of the sentinel node in breast cancer
    Procedure: GAS
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293865

Locations
France
Hospîtal
Angers, France, 49000
Institut Bergonié
Bordeaux, France, 33076
Hospital
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
Hospital
Nancy, France, 54511
Hopital Lariboisière
Paris, France, 75 000
Hopital Européen Georges Pompidou
Paris, France, 75000
Hôpital Tenon
Paris, France, 75970
Hospital
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
Investigators
Principal Investigator: Jean Marc Classe, MD Centre Rene Gauducheau
  More Information

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT00293865     History of Changes
Other Study ID Numbers: BRD 05/11-M 
Study First Received: February 17, 2006
Last Updated: April 18, 2016
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on December 02, 2016