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临床试验/NCT07528287
NCT07528287尚未招募不适用

Study on Biomarkers of Radiation-Induced Intestinal Injury

Tongji Hospital0 个研究点目标入组 220 人开始时间: 2026年4月1日最近更新:
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

  1. To identify biomarkers of radiation-induced intestinal injury;
  2. To develop a predictive model for radiation-induced intestinal injury.

详细描述

  1. Enroll eligible patients and obtain written informed consent.
  2. Collect clinical data.
  3. 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.
  4. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

bo liu

Associate Professor

Tongji Hospital

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