Study on Biomarkers of Radiation-Induced Intestinal Injury

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

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Lingyan Xiao; Phone Number: 027-15971474885; Email: lingyanxiao@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine

Description

Inclusion Criteria:

1. Abdominal radiotherapy dose ≥45 Gy;
2. Age ≥18 years;
3. Karnofsky Performance Status (KPS) >60;
4. Expected survival >6 months.

Exclusion Criteria:

1. Prior history of abdominal radiotherapy;
2. Active intestinal infection;
3. Intestinal inflammatory diseases due to other causes;
4. Inability to provide biological samples.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation-induced intestinal injury	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 years

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Bo Liu, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TJ202512216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No