NCT07528287

Study on Biomarkers of Radiation-Induced Intestinal Injury

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Radiation-induced Intestinal Injury

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-12-01
• Completion: 2031-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14