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临床试验/NCT05091255
NCT05091255招募中不适用

Cryotherapy in the Treatment of Desmoid Tumors

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
94
试验地点
2
主要终点
response to treatment

研究概览

简要总结

Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • histologic diagnosis of desmoid tumors
  • age > 18 years
  • abdominal and extra-abdominal desmoid tumors

排除标准

  • contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
  • retroperitoneal desmoid tumors
  • age < 18 years

结局指标

主要结局

response to treatment

时间窗: At baseline (time 0)

assessment of tumor response to treatment will be performed using the solid tumor response criteria

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Costantino Errani

Principal Investigator

Istituto Ortopedico Rizzoli

研究点 (2)

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Cryotherapy in the Treatment of Desmoid Tumors | 临床试验