NCT03142425Unknown不适用
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
DxTerity Diagnostics2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Collection of blood samples from patients prior to and post irradiation treatment.
研究概览
简要总结
Collect blood samples and associated clinical data prior to and post radiation treatment.
详细描述
Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female patients age 18 or older
- •Diagnosed with a primary rectal or esophageal cancer
- •Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
- •Combining chemotherapy is allowed
- •ECOG Performance Status 0-2
- •Able to provide written informed consent
排除标准
- •Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
- •Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study
结局指标
主要结局
Collection of blood samples from patients prior to and post irradiation treatment.
时间窗: Up to 4 months, from informed consent through follow up activities.
Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment.
次要结局
未报告次要终点
研究者
研究点 (2)
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