Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer (GATA)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sentinel node
GAS
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast infiltrative cancer
Eligibility 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
Sites / Locations
- Hospîtal
- Institut Bergonié
- Hospital
- Centre Hospitalier
- Centre Oscar Lambret
- centre Léon Berard
- Institut Paoli Calmette
- Centre Alexis Vautrin
- Hospital
- Hopital Lariboisière
- Hopital Européen Georges Pompidou
- Hôpital Tenon
- Hospital
- Institut Jean Godinot
- Centre Eugène Marquis
- Centre René Gauducheau
- Centre Claudius Regaud
Outcomes
Primary Outcome Measures
false negatives
Secondary Outcome Measures
Full Information
NCT ID
NCT00293865
First Posted
February 17, 2006
Last Updated
April 18, 2016
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT00293865
Brief Title
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Acronym
GATA
Official Title
Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast infiltrative cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
sentinel node
Intervention Description
detection of the sentinel node in breast cancer
Intervention Type
Procedure
Intervention Name(s)
GAS
Primary Outcome Measure Information:
Title
false negatives
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marc Classe, MD
Organizational Affiliation
Centre Rene Gauducheau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospîtal
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospital
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Centre Hospitalier
City
La roche sur yon
ZIP/Postal Code
85000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
centre Léon Berard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hospital
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75 000
Country
France
Facility Name
Hopital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35062
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27214241
Citation
Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.
Results Reference
derived
Learn more about this trial
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
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