NCT07528313

Brief Summary

  1. 1.To identify biomarkers of radiation-induced bladder injury;
  2. 2.To develop a predictive model for radiation-induced bladder injury.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2031

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Radiation-Induced Bladder Injury

Outcome Measures

Primary Outcomes (1)

  • radiation-induced bladder injury

    radiation-induced bladder injury

    1 year

Secondary Outcomes (1)

  • overall survival

    5 years

Study Arms (1)

Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant tumors undergoing abdominal radiotherapy that may involve the bladder

You may qualify if:

  • Abdominal radiation dose ≥ 45 Gy
  • Age ≥ 18 years
  • Karnofsky Performance Status (KPS) \> 60
  • Expected survival \> 6 months.

You may not qualify if:

  • Prior history of abdominal radiotherapy;
  • Presence of active intestinal infection;
  • Presence of other causes of inflammatory bowel disease;
  • Inability to provide biological samples.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

  • Bo Liu

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingyan Xiao

CONTACT

027-15971474885lingyanxiao@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share