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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre René Gauducheau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT00293865
First received: February 17, 2006
Last updated: October 11, 2010
Last verified: October 2010
  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 Centre René Gauducheau:

Primary Outcome Measures:
  • false negatives

Estimated Enrollment: 203
Study Start Date: March 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (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
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

Contacts
Contact: Jean Marc Classe, MD 33240679959 jm-classe@nantes.fnclcc.fr

Locations
France
Hospîtal Recruiting
Angers, France, 49000
Contact: Philippe Descamps, MD         
Principal Investigator: Philippe Descamp, MD         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Principal Investigator: C Tunon de Lara, MD         
Sub-Investigator: Françoise Bonichon, MD         
Hospital Recruiting
Brest, France, 29000
Principal Investigator: Pierre François Dupré, MD         
Centre Hospitalier Recruiting
La roche sur yon, France, 85000
Contact: Carole damey, MD         
Principal Investigator: Carole Damey, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Principal Investigator: Giard Sylvia, MD         
Sub-Investigator: Carpentier Philippe, MD         
centre Léon Berard Recruiting
Lyon, France, 69000
Contact: Mignotte Hervé, MD         
Principal Investigator: Herve Mignotte, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13273
Principal Investigator: G Houvenaeghel, MD         
Sub-Investigator: Pasquier, MD         
Centre Alexis Vautrin Recruiting
Nancy, France, 54000
Contact: Jean Luc Verhaeghe, MD         
Principal Investigator: Jean Luc Verhaeghe, MD         
Hospital Active, not recruiting
Nancy, France, 54511
Hôpital Tenon Recruiting
Paris, France, 75970
Contact: Emile Daraï, MD         
Principal Investigator: Emile Daraï, MD         
Hopital Lariboisière Recruiting
Paris, France, 75 000
Contact: Emmanuel Barranger, MD         
Principal Investigator: Emmanuel Barranger, MD         
Hopital Européen Georges Pompidou Recruiting
Paris, France, 75000
Principal Investigator: Fabrice Lecuru, MD         
Hospital Recruiting
Poitiers, France, 86000
Contact: Guillaume Magnin, MD         
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Jean Claude Liehn, MD         
Principal Investigator: Jean Claude Liehn, MD         
Centre Eugène Marquis Recruiting
Rennes, France, 35062
Principal Investigator: Jean Levêque, MD         
Sub-Investigator: Anne Devillers, MD         
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Jean MArc Classe, MD    +33240679900      
Principal Investigator: Jean Marc Classe, MD         
Centre Claudius Regaud Recruiting
Toulouse, France, 31052
Principal Investigator: Martel, MD         
Sub-Investigator: Frédéric Courbon, MD         
Sponsors and Collaborators
Centre René Gauducheau
Investigators
Principal Investigator: Jean Marc Classe, MD Centre Rene Gauducheau
  More Information

No publications provided

Responsible Party: Mme Scotet-Cérato, Centre René Gauducheau
ClinicalTrials.gov Identifier: NCT00293865     History of Changes
Other Study ID Numbers: BRD 05/11-M
Study First Received: February 17, 2006
Last Updated: October 11, 2010
Health Authority: France: Ministry of Health

Keywords provided by Centre René Gauducheau:
Breast infiltrative cancer

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

ClinicalTrials.gov processed this record on August 28, 2014