Sentinel Lymph Node Technique in Multifocal Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sentinel Lymph Node Technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring adenocarcinoma, breast, multifocal lesions, surgery
Eligibility Criteria
Inclusion Criteria:
- Multifocal invasive breast cancer
- At least 2 focuses (clinically and/or by mammography or ultrasound)
- Proven by pre-surgical histology (on 1 focus at least)
- Age > 18 years old
- Clinically negative axillary lymph nodes
- No treatment before surgery
- Signature of written informed consent
Exclusion Criteria:
- Multifocality proven after surgery
- Non invasive breast cancer
- Inflammatory breast cancer
- Axillary lymph node
- Metastatic disease
- Previous homolateral breast cancer
- Dementia or alterated mental status
- Pregnant or lactating woman
Sites / Locations
- Centre Hospitalier Universitaire
- Centre Paul Papin
- Institut Bergonie
- Centre Jean Perrin
- Clinique de Flandre
- Centre Georges-Francois LECLERCQ
- Centre Oscar Lambret
- Centre Leon Berard
- Institut Paoli Calmettes
- CRLC Val d'Aurelle
- Hôpital Lariboisière
- Hopital Tenon
- Centre Eugene Marquis
- Centre Henri Becquerel
- Centre Hospitalier Sud Léman Valsérine
- Centre Rene Gauducheau
- Hôpital Georges PIANTA
- Centre Claudius Regaud
- Centre Hospitalier
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
detection rate of sentinel nodes
Secondary Outcome Measures
number of sentinel nodes removed
localisation of the sentinel nodes
Full Information
NCT ID
NCT00417495
First Posted
December 29, 2006
Last Updated
January 5, 2016
Sponsor
Centre Oscar Lambret
1. Study Identification
Unique Protocol Identification Number
NCT00417495
Brief Title
Sentinel Lymph Node Technique in Multifocal Breast Cancer
Official Title
Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
5. Study Description
Brief Summary
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer
Detailed Description
The sentinel lymph node is located preferentially by:
association of subareolar injection of technecium and blue dye
or, in case of blue dye allergy, by the subareolar injection of technecium only
or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
This procedure is immediately follows by complete axillary dissection during breast surgery
The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
adenocarcinoma, breast, multifocal lesions, surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Sentinel Lymph Node Technique
Primary Outcome Measure Information:
Title
detection rate of sentinel nodes
Time Frame
surgery
Secondary Outcome Measure Information:
Title
number of sentinel nodes removed
Time Frame
surgery
Title
localisation of the sentinel nodes
Time Frame
surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Multifocal invasive breast cancer
At least 2 focuses (clinically and/or by mammography or ultrasound)
Proven by pre-surgical histology (on 1 focus at least)
Age > 18 years old
Clinically negative axillary lymph nodes
No treatment before surgery
Signature of written informed consent
Exclusion Criteria:
Multifocality proven after surgery
Non invasive breast cancer
Inflammatory breast cancer
Axillary lymph node
Metastatic disease
Previous homolateral breast cancer
Dementia or alterated mental status
Pregnant or lactating woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GIARD Sylvia, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Clinique de Flandre
City
Coudekerque Branche
ZIP/Postal Code
59210
Country
France
Facility Name
Centre Georges-Francois LECLERCQ
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
130009
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Hospitalier Sud Léman Valsérine
City
SAINT JULIEN en GENEVOIS
ZIP/Postal Code
74167
Country
France
Facility Name
Centre Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Georges PIANTA
City
THONON-les-BAINS
ZIP/Postal Code
74203
Country
France
Facility Name
Centre Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94808
Country
France
12. IPD Sharing Statement
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Sentinel Lymph Node Technique in Multifocal Breast Cancer
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