NCT07528287尚未招募不适用
Study on Biomarkers of Radiation-Induced Intestinal Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Radiation-induced intestinal injury
研究概览
简要总结
- To identify biomarkers of radiation-induced intestinal injury;
- To develop a predictive model for radiation-induced intestinal injury.
详细描述
- Enroll eligible patients and obtain written informed consent.
- Collect clinical data.
- Sample collection and biomarker assessment: Peripheral blood, urine, and stool samples will be collected from patients before the initiation of radiotherapy and after the start of radiotherapy, followed by multi-omics analyses.
- Patient follow-up: Patients will be followed during radiotherapy, within 1 month after completion of treatment, and every 3 months thereafter; after 1 year, follow-up will be conducted every 6 months. Patients' symptoms, laboratory tests, and examination results will be recorded. Radiation-induced intestinal injury and its grading will be assessed according to the Radiation Therapy Oncology Group (RTOG) criteria. In addition, treatments and outcomes after the occurrence of radiation-induced intestinal injury will be documented.
The primary endpoint is radiation-induced intestinal injury, and the secondary endpoint is overall survival. 5. Data integration: Clinical data, previous research findings, and biomarkers measured from patient samples will be integrated to identify biomarkers of radiation-induced intestinal injury and to develop a predictive model using bioinformatics approaches.
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
- •Abdominal radiotherapy dose ≥45 Gy;
- •Age ≥18 years;
- •Karnofsky Performance Status (KPS) >60;
- •Expected survival >6 months.
排除标准
- •Prior history of abdominal radiotherapy;
- •Active intestinal infection;
- •Intestinal inflammatory diseases due to other causes;
- •Inability to provide biological samples.
研究组 & 干预措施
Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine
结局指标
主要结局
Radiation-induced intestinal injury
时间窗: 1 year
次要结局
- overall survival(5 years)
研究者
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