Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
研究概览
简要总结
Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cancer patients
- •Appropriate liver, renal, and bone marrow function for radiotherapy
- •Willing to provide informed written consent
- •At least 20 years old
排除标准
- •prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery
- •Any contraindication to radiotherapy (i.e. Severe connective tissue disorder, etc.)
- •Prior or simultaneous history of other malignancy
- •On medication for small bowel disease or CTCAE 4.0 Grade 1 or higher toxicity before radiation
- •Any treatment delay more than 1 week during radiotherapy
- •No radiotherapy due to any other reason except small bowel toxicity
研究组 & 干预措施
Plasma citrulline
干预措施: Plasma citrulline (Biological)
结局指标
主要结局
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
时间窗: 1 year
次要结局
- Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.(1 year)
研究者
Young Seok Kim
Assistant Professor
Asan Medical Center