NCT01849107已完成不适用
Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 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
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
研究点 (2)
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