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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01035268
First received: December 14, 2009
Last updated: March 26, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: fatty tissue transfer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: January 2010
Estimated Study Completion Date: August 2026
Estimated Primary Completion Date: August 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035268

Locations
France
CHU de Besançon
Besançon, France, 25030
Clinique Saint Antoine
Bois-Guillaume, France, 76230
CHU Pellegrin
Bordeaux, France, 33076
Institut Bergonie
Bordeaux, France, 33076
Pole de Sante de Leonard de Vinci
Chambray-Les-Tours, France, 37145
Hopital Henri Mondor
Créteil, France, 94010
Centre Hospitalier La Croix Rousse
Lyon, France, 69004
Hopital Edouard Herriot
Lyon, France, 69437
CHR Marseille Conception
Marseille, France, 13005
Institut Paoli Calmettes
Marseille, France, 13273
Centre Val d'Aurelle
Montpellier, France, 34298
Clinique Brétéché
Nantes, France, 44000
Hopital Saint Louis
Paris, France, 75010
INSTITUT CURIE - Site Paris
Paris, France, 75005
Centre Eugene Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
INSTITUT CURIE - René Huguenin
Saint-Cloud, France, 92210
INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
Saint-Herblain, France, 44805
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
CHU Rangueil
Toulouse, France, 31000
Institut Claudius Regaud
Toulouse, France, 31059
Centre Alexis Vautrin
Vandoeuvre-lès-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Ignacio GARRIDO, MD Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01035268     History of Changes
Other Study ID Numbers: 08 SEIN 08
Study First Received: December 14, 2009
Last Updated: March 26, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
breast cancer treated by conservative surgery

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 30, 2015