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

NCT ID: NCT00293865

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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sentinel node

detection of the sentinel node in breast cancer

Intervention Type PROCEDURE

GAS

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Marc Classe, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Rene Gauducheau

Locations

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Hospîtal

Angers, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Hospital

Brest, , France

Site Status

Centre Hospitalier

La Roche-sur-Yon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

centre Léon Berard

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Centre Alexis Vautrin

Nancy, , France

Site Status

Hospital

Nancy, , France

Site Status

Hopital Lariboisière

Paris, , France

Site Status

Hopital Européen Georges Pompidou

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hospital

Poitiers, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Centre René Gauducheau

Saint-Herblain, , France

Site Status

Centre Claudius Regaud

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27214241 (View on PubMed)

Other Identifiers

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BRD 05/11-M

Identifier Type: -

Identifier Source: org_study_id

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