Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella (GRATSEC)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Besançon、法国、25030
- CHU de Besançon
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Bois-Guillaume、法国、76230
- Clinique Saint Antoine
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Bordeaux、法国、33076
- Institut Bergonie
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Bordeaux、法国、33076
- CHU Pellegrin
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Chambray-Les-Tours、法国、37145
- Pole de Sante de Leonard de Vinci
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Créteil、法国、94010
- Hopital Henri Mondor
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Lyon、法国、69437
- Hôpital Edouard Herriot
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Lyon、法国、69004
- Centre Hospitalier La Croix Rousse
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Marseille、法国、13273
- Institut Paoli Calmettes
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Marseille、法国、13005
- CHR Marseille Conception
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Montpellier、法国、34298
- Centre Val d'Aurelle
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Nantes、法国、44000
- Clinique Brétéché
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Paris、法国、75010
- Hopital Saint Louis
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Paris、法国、75005
- Institut Curie - Site Paris
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Rennes、法国、35042
- Centre Eugene Marquis
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Rouen、法国、76038
- Centre Henri Becquerel
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Saint-Cloud、法国、92210
- INSTITUT CURIE - René Huguenin
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Saint-Herblain、法国、44805
- Institut de Cancérologie de l'Ouest - Centre René Gauducheau
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Strasbourg、法国、67091
- Hopitaux Universitaires de Strasbourg
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Toulouse、法国、31059
- Institut Claudius Regaud
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Toulouse、法国、31000
- CHU Rangueil
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Vandoeuvre-lès-Nancy、法国、54511
- Centre Alexis Vautrin
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Villejuif、法国、94805
- Institut Gustave Roussy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：surgery by fatty tissue transfer
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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.
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无干预：simple supervision
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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.
大体时间：1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
大体时间：1 year
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1 year
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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.
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员：Ignacio GARRIDO, MD、Institut Claudius Regaud
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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