NCT00293865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

6 years

First QC Date

February 17, 2006

Last Update Submit

April 18, 2016

Conditions

Breast Cancer

Keywords

Breast infiltrative cancer

Outcome Measures

Primary Outcomes (1)

  • false negatives

Interventions

sentinel nodePROCEDURE

detection of the sentinel node in breast cancer

GASPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospîtal

Angers, 49000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Hospital

Brest, 29000, France

Location

Centre Hospitalier

La Roche-sur-Yon, 85000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

centre Léon Berard

Lyon, 69000, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

Centre Alexis Vautrin

Nancy, 54000, France

Location

Hospital

Nancy, 54511, France

Location

Hopital Lariboisière

Paris, 75 000, France

Location

Hopital Européen Georges Pompidou

Paris, 75000, France

Location

Hôpital Tenon

Paris, 75970, France

Location

Hospital

Poitiers, 86000, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugène Marquis

Rennes, 35062, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Claudius Regaud

Toulouse, 31052, France

Location

Related Publications (1)

  • 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.

    PMID: 27214241DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Jean Marc Classe, MD

    Centre Rene Gauducheau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

FR(17)