NCT01188915终止不适用
Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001
Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2010年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- efficacy of the screening
研究概览
简要总结
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.
The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •women > 18 years
- •treated for Hodgkin disease
- •signed informed consent
- •high risk of breast cancer
排除标准
- •patients unable to have a regular follow-up
研究组 & 干预措施
intensive screening
Experimental
annual breast cancer detection based on mammography, echography and RMI.
干预措施: intensive screening (Procedure)
结局指标
主要结局
efficacy of the screening
时间窗: 15 years
The efficacy of the screening will be evaluated by the rate of early stage breast cancer detected. The rate of in situ, \< 10 mm(T1b), and N0 will be estimated.
次要结局
- interest(1 month)
- adhesion(1 month)
- compliance(15 years)
- psychologic impact(15 years)
研究者
研究点 (1)
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