跳至主要内容
临床试验/NCT04130373
NCT04130373Unknown不适用

Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting

Humanitas Clinical and Research Center1 个研究点 分布在 1 个国家目标入组 6,510 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
6,510
试验地点
1
主要终点
Oncological safety of autologous fat grafting

研究概览

简要总结

Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
  • group treated with lipofilling and group which didnt receive lipofilling
  • timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up

排除标准

  • neoplasie different from infiltrating and in sutu breast carcinoma
  • in situ lobular carcinoma
  • patients with breast carcinoma and metastasis
  • lipofilling procedure used before the oncological treatment for breast carcinoma

结局指标

主要结局

Oncological safety of autologous fat grafting

时间窗: Two years

Percentage of disease relapse in loco

次要结局

  • Establishment of timing in disease relapse(Two years)
  • Establish overall survival rate in experimental and control groups(Two years)
  • Establish the distribution in disease relapses(Two years)

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Lisa

MD

Humanitas Clinical and Research Center

研究点 (1)

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