NCT01801176已完成不适用
Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Peripheral primitive fibromatosis
- •Adults patients
- •Peripheral primitive fibromatosis proved by biopsy
- •Peripheral primitive fibromatosis R2 resected for which monitoring is decided
- •MRI realized before inclusion
- •Patient information and informed consent signed
排除标准
- •Local recur
- •Head and neck topography
- •Primitive fibromatosis R0 or R1 resected
- •Specific medical treatment of fibromatosis
- •Patient already included in an other clinical trial with an experimental molecule
- •Persons deprived of liberty
- •Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons
- •Previous history of cancer
- •Counter indication to the realization of an MRI
研究组 & 干预措施
Initial monitoring group
Experimental
干预措施: MRI (Other)
结局指标
主要结局
Progression Free Survival
时间窗: assessed up to 3 years
次要结局
- Functional result(1 year)
研究者
研究点 (1)
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