Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast infiltrative cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: sentinel node Type: Procedure
Name: GAS Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Locations
Hospîtal
Angers, France
Status: Recruiting
Contact: Philippe Descamps, MD
Institut Bergonié
Bordeaux, France
Status: Recruiting
Hospital
Brest, France
Status: Recruiting
Centre Hospitalier
La roche sur yon, France
Status: Recruiting
Contact: Carole damey, MD
Centre Oscar Lambret
Lille, France
Status: Recruiting
centre Léon Berard
Lyon, France
Status: Recruiting
Contact: Mignotte Hervé, MD
Institut Paoli Calmette
Marseille, France
Status: Recruiting
Centre Alexis Vautrin
Nancy, France
Status: Recruiting
Contact: Jean Luc Verhaeghe, MD
Hospital
Nancy, France
Status: Active, not recruiting
Hopital Européen Georges Pompidou
Paris, France
Status: Recruiting
Hopital Lariboisière
Paris, France
Status: Recruiting
Contact: Emmanuel Barranger, MD
Hôpital Tenon
Paris, France
Status: Recruiting
Contact: Emile Daraï, MD
Hospital
Poitiers, France
Status: Recruiting
Contact: Guillaume Magnin, MD
Institut Jean Godinot
Reims, France
Status: Recruiting
Contact: Jean Claude Liehn, MD
Centre Eugène Marquis
Rennes, France
Status: Recruiting
Centre René Gauducheau
Saint Herblain, France
Status: Recruiting
Contact: Jean MArc Classe, MD - +33240679900
Centre Claudius Regaud
Toulouse, France
Status: Recruiting
Start Date
March 2006
Completion Date
March 2011
Sponsors
Centre René Gauducheau
Source
Centre René Gauducheau
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page