Radiation-Induced Bladder Injury
Conditions
Brief summary
1. To identify biomarkers of radiation-induced bladder injury; 2. To develop a predictive model for radiation-induced bladder 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 bladder injury will be documented. The primary endpoint is radiation-induced bladder 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 bladder injury and to develop a predictive model using bioinformatics approaches.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Abdominal radiation 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. Presence of active intestinal infection; 3. Presence of other causes of inflammatory bowel disease; 4. Inability to provide biological samples.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiation-induced bladder injury | 1 year | radiation-induced bladder injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | overall survival |
Contacts
Tongji Hospital