Study on Biomarkers of Radiation-Induced Bladder Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Radiation-Induced Bladder Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- radiation-induced bladder injury [Time frame: 1 year]
Secondary outcome measures (1)
- overall survival [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Abdominal radiation dose ≥ 45 Gy
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) > 60
- Expected survival > 6 months.
Exclusion criteria
- Prior history of abdominal radiotherapy;
- Presence of active intestinal infection;
- Presence of other causes of inflammatory bowel disease;
- Inability to provide biological samples.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07528313 · TJ202512217