Study on Biomarkers of Radiation-Induced Intestinal Injury

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07528287

Enrollment

220

Registered

2026-04-14

Start date

2026-04-01

Completion date

2031-12-01

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation-induced Intestinal Injury

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Radiation-induced intestinal injury	1 year

Secondary

Measure	Time frame
overall survival	5 years

Contacts

CONTACTLingyan Xiao

lingyanxiao@hust.edu.cn027-15971474885

PRINCIPAL_INVESTIGATORBo Liu

Tongji Hospital

Outcome results