Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
This trial is active, not recruiting.
|Treatment||fatty tissue transfer|
|Sponsor||Institut Claudius Regaud|
|Start date||January 2010|
|End date||August 2026|
|Trial size||440 participants|
|Trial identifier||NCT01035268, 08 SEIN 08|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Besançon, France||CHU de Besançon||no longer recruiting|
|Bois-Guillaume, France||Clinique Saint Antoine||no longer recruiting|
|Bordeaux, France||CHU Pellegrin||no longer recruiting|
|Bordeaux, France||Institut Bergonie||no longer recruiting|
|Chambray-Les-Tours, France||Pole de Sante de Leonard de Vinci||no longer recruiting|
|Créteil, France||Hopital Henri Mondor||no longer recruiting|
|Lyon, France||Centre Hospitalier La Croix Rousse||no longer recruiting|
|Lyon, France||Hopital Edouard Herriot||no longer recruiting|
|Marseille, France||CHR Marseille Conception||no longer recruiting|
|Marseille, France||Institut Paoli Calmettes||no longer recruiting|
|Montpellier, France||Centre Val d'Aurelle||no longer recruiting|
|Nantes, France||Clinique Brétéché||no longer recruiting|
|Paris, France||Hopital Saint Louis||no longer recruiting|
|Paris, France||INSTITUT CURIE - Site Paris||no longer recruiting|
|Rennes, France||Centre Eugene Marquis||no longer recruiting|
|Rouen, France||Centre Henri Becquerel||no longer recruiting|
|Saint-Cloud, France||INSTITUT CURIE - René Huguenin||no longer recruiting|
|Saint-Herblain, France||INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau||no longer recruiting|
|Strasbourg, France||Hôpitaux Universitaires de Strasbourg||no longer recruiting|
|Toulouse, France||CHU Rangueil||no longer recruiting|
|Toulouse, France||Institut Claudius Regaud||no longer recruiting|
|Vandoeuvre-lès-Nancy, France||Centre Alexis Vautrin||no longer recruiting|
|Villejuif, France||Institut Gustave Roussy||no longer recruiting|
|Intervention model||parallel assignment|
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
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
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
Female participants at least 18 years old.
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.
|Official title||Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment|
|Principal investigator||Ignacio GARRIDO, MD|
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