Radiation-Induced Bladder InjuryNCT07528313
Study on Biomarkers of Radiation-Induced Bladder Injury
An observational study of Radiation-Induced Bladder Injury, run by Tongji Hospital.
Trial summary
1. To identify biomarkers of radiation-induced bladder injury; 2. To develop a predictive model for radiation-induced bladder injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Bladder Injury
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder
Who may be able to join
- Abdominal radiation dose ≥ 45 Gy
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) > 60
- Expected survival > 6 months.
Who cannot join
- Prior history of abdominal radiotherapy;
- Presence of active intestinal infection;
- Presence of other causes of inflammatory bowel disease;
- Inability to provide biological samples.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- To identify biomarkers of radiation-induced bladder injury;
- To develop a predictive model for radiation-induced bladder injury.
Read the detailed description
- 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 bladder injury will be documented. The primary endpoint is radiation-induced bladder 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 bladder injury and to develop a predictive model using bioinformatics approaches.
- Conditions
- Radiation-Induced Bladder Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation-induced bladder injury
radiation-induced bladder injury
Measured: 1 year
Secondary outcomes (1)
overall survival
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced Bladder InjuryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo liu, Tongji Hospital
- Investigators
- Bo Liu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528313
- Sponsor's protocol ID
- TJ202512217
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Biomarkers of Radiation-Induced Bladder Injury
- ClinicalTrials.gov ID
- NCT07528313
- Acronym / sponsor ID
- TJ202512217
- Conditions
- Radiation-Induced Bladder Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To identify biomarkers of radiation-induced bladder injury;
- To develop a predictive model for radiation-induced bladder injury.
Detailed description
- 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 bladder injury will be documented. The primary endpoint is radiation-induced bladder 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 bladder injury and to develop a predictive model using bioinformatics approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder
Key inclusion criteria (4 listed)
- Abdominal radiation dose ≥ 45 Gy
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) > 60
- Expected survival > 6 months.
Key exclusion criteria (4 listed)
- Prior history of abdominal radiotherapy;
- Presence of active intestinal infection;
- Presence of other causes of inflammatory bowel disease;
- Inability to provide biological samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
radiation-induced bladder injury
Time frame: 1 year
radiation-induced bladder injury
1 secondary outcome
overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Radiation-Induced Bladder Injury
RecruitingObservational study
Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Liu principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-Induced Bladder Injury, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyan Xiao (027-15971474885, lingyanxiao@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation-induced bladder injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.