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Study on Biomarkers of Radiation-Induced Bladder Injury

Study on Biomarkers of Radiation-Induced Bladder Injury

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07528313
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 Bladder Injury

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

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
radiation-induced bladder injury1 yearradiation-induced bladder injury

Secondary

MeasureTime frameDescription
overall survival5 yearsoverall survival

Contacts

CONTACTLingyan Xiao
lingyanxiao@hust.edu.cn027-15971474885
PRINCIPAL_INVESTIGATORBo Liu

Tongji Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026