Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer

NARecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

September 1, 2027

Conditions
Bladder CancerLiquid BiopsyCystoscopy
Interventions
DIAGNOSTIC_TEST

utDNA testing + Urine Cytology

Participants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

DIAGNOSTIC_TEST

Cystoscopy + Urine Cytology

Participants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

Trial Locations (1)

300000

RECRUITING

The second hospital of Tianjin Medical University, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Second Hospital

OTHER

NCT07180212 - Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer | Biotech Hunter | Biotech Hunter