Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
NCT ID: NCT01035268
Last Updated: 2018-08-22
Study Results
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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TERMINATED
PHASE3
196 participants
INTERVENTIONAL
2010-02-08
2017-02-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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surgery by fatty tissue transfer
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.
simple supervision
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Principal Investigators
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Ignacio GARRIDO, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Locations
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CHU de Besançon
Besançon, , France
Clinique Saint Antoine
Bois-Guillaume, , France
CHU Pellegrin
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Pole de Sante de Leonard de Vinci
Chambray-lès-Tours, , France
Hopital Henri Mondor
Créteil, , France
Centre Hospitalier La Croix Rousse
Lyon, , France
Hopital Edouard Herriot
Lyon, , France
CHR Marseille Conception
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Val d'Aurelle
Montpellier, , France
Clinique Brétéché
Nantes, , France
INSTITUT CURIE - Site Paris
Paris, , France
Hopital Saint Louis
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
INSTITUT CURIE - René Huguenin
Saint-Cloud, , France
INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
Saint-Herblain, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
CHU Rangueil
Toulouse, , France
Institut Claudius Regaud
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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08 SEIN 08
Identifier Type: -
Identifier Source: org_study_id
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