Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella (GRATSEC)

August 21, 2018 updated by: Institut Claudius Regaud

Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besançon
      • Bois-Guillaume, France, 76230
        • Clinique Saint Antoine
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, 33076
        • CHU Pellegrin
      • Chambray-Les-Tours, France, 37145
        • Pole de Sante de Leonard de Vinci
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Lyon, France, 69004
        • Centre Hospitalier La Croix Rousse
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France, 13005
        • CHR Marseille Conception
      • Montpellier, France, 34298
        • Centre Val d'Aurelle
      • Nantes, France, 44000
        • Clinique Brétéché
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75005
        • Institut Curie - Site Paris
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92210
        • INSTITUT CURIE - René Huguenin
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
      • Strasbourg, France, 67091
        • Hopitaux Universitaires de Strasbourg
      • Toulouse, France, 31059
        • Institut Claudius Regaud
      • Toulouse, France, 31000
        • CHU Rangueil
      • Vandoeuvre-lès-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • History of breast cancer treated by conservative surgery .
  • Normal inclusion radiological assessment normal (ACR1 or ACR2)
  • Moderate Deformations (Type I and II of the classification of Clough).
  • Delay with regard to the end of the radiotherapy superior or equal to one-year-old.
  • Moderated radio-dystrophies (< Grade 2 of the score LENT/SOMA).
  • Signature of the informed consent
  • Patient benefiting from social security
  • Patient of more than 18 years old

Exclusion Criteria:

  • Abnormal radiological assessment (ACR3, ACR4 or ACR5)
  • Absence of fatty excess .
  • radio surgical relapses with vast fibroses of the breast (> Grade 2 of the score LENT/SOMA).
  • Patient under 18 years old.
  • administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .
  • pregnant women or breast feeding women
  • patient under legal guardianship
  • bilateral breast cancer regardless histologic type.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surgery by fatty tissue transfer
Procedure: fatty tissue transfer
It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.
No Intervention: simple supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
Time Frame: 1 year
1 year
Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Ignacio GARRIDO, MD, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2010

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

February 21, 2017

Study Registration Dates

First Submitted

December 14, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 SEIN 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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