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Slow recruitment rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery by fatty tissue transfer | Experimental |
| |
| simple supervision | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fatty tissue transfer | Procedure | 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. |
| Measure | Description | 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. | 1 year |
| Measure | Description | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio GARRIDO, MD | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25030 | France | |||
| Clinique Saint Antoine |
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| 1 year |
| Bois-Guillaume |
| 76230 |
| France |
| CHU Pellegrin | Bordeaux | 33076 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Pole de Sante de Leonard de Vinci | Chambray-lès-Tours | 37145 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier La Croix Rousse | Lyon | 69004 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| CHR Marseille Conception | Marseille | 13005 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Clinique Brétéché | Nantes | 44000 | France |
| INSTITUT CURIE - Site Paris | Paris | 75005 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| INSTITUT CURIE - René Huguenin | Saint-Cloud | 92210 | France |
| INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| CHU Rangueil | Toulouse | 31000 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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