Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
研究概览
简要总结
Breast cancer is the most common cancer in the world. Half of patients with such cancer are treated with radiation therapy. Some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome. Several studies have shown a correlation between an inflammatory reaction and a protein, called TREM-1. But to date, no link has been proven between TREM-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer. Our study aims to understand the involvement of this TREM-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •for groups A, B, C, D:
- •Systemic inflammatory disease associated with individual radiosensitivity
- •Dermatological pathology in the breast
- •Radiotherapy having delivered an overdose> 107% of the prescribed dose in at least 10% of the PTV
- •Active smoking
- •Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-TNF
排除标准
- 未提供
结局指标
主要结局
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
时间窗: after recruitment of all samples, an average of 2 years
Correlate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
次要结局
- Intrinsic characteristics of the TREM1 blood assay in ELISA technique(after recruitment of all samples, an average of 2 years)
- Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy(after recruitment of all samples, an average of 2 years)
- correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha(after recruitment of all samples, an average of 2 years)