Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject
研究概览
简要总结
Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.
详细描述
Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 48 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer treatment: lumpectomy followed by external beam XRT to breast
- •Age at the time of radiotherapy treatment: 45-65 years old
- •XRT dose to breast: >/= 4500 and </= 5200 cGy, fraction size 180 or 200 cGy
- •Dose distribution: no area receiving >/= 112% of prescribed dose
- •Follow-ups: patients must be >/= 2.5 years post-treatment
排除标准
- •Reconstructive surgery to involved breast
结局指标
主要结局
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject
时间窗: at least 2.5 years following lumpectomy and radiation therapy
次要结局
未报告次要终点