Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 196
- 试验地点
- 46
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
surgery by fatty tissue transfer
干预措施: fatty tissue transfer (Procedure)
simple supervision
结局指标
主要结局
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.
时间窗: 1 year
次要结局
- 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.(1 year)