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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiation-induced intestinal injury | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with malignant tumors undergoing abdominal radiotherapy that may involve the intestine
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingyan Xiao | Contact | 027-15971474885 | lingyanxiao@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bo Liu | Tongji Hospital | Principal Investigator |
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