NCT00922961已完成不适用
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
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
- 25
- 试验地点
- 2
- 主要终点
- Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
研究概览
简要总结
25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.
During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)
详细描述
This is an interventional study for the french law
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
- •Patient with social security
排除标准
- •Not applicable
研究组 & 干预措施
cellular apoptosis
Experimental
干预措施: Blood sample (Biological)
cellular apoptosis
Experimental
干预措施: Clinical exam (Procedure)
结局指标
主要结局
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
时间窗: Blood sample during a consultation
次要结局
- Assessment of the rate of sequellar pain(During a consultation with 2 physicians)
- Assessment of the rate and scores of late fibrosis related to irradiation by mammosite(During a consultation with 2 physicians)
- Assessment of the rate of seroma collection(During a consultation with 2 physicians)
- Assessment of the breast esthetic score(During a consultation with 2 physicians)
- Assessment of the rate of telangiectasia(During a consultation with 2 physicians)
研究者
研究点 (2)
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