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

NCT07180212 | Recruiting

• 1 other identifier: Truce-LB02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology. Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients. This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods. By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.

Conditions

Bladder Cancer; Liquid Biopsy; Cystoscopy

Keywords

bladder cancer; liquid biopsy; cystoscopy; urine tumor DNA

Outcome Measures

Primary Outcomes (2)

• Recurrence-Free Survival (RFS)

  Time from randomization to the first histologically confirmed intravesical tumor recurrence (any grade/stage).

  Up to 24 months from randomization.

• Mean Number of Cystoscopic Examinations per Patient Within 2 Years

  The mean number of cystoscopic examinations per patient within 2 years was calculated for both the intervention group and the control group. This measure represents the average total number of cystoscopy procedures undergone by each participant during the 24-month follow-up period.

  Up to 24 months from randomization.

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

  Up to 24 months from randomization.

• Sensitivity of serial utDNA testing for detection of intravesical recurrence

  From randomization to 24 months.

• Specificity of serial utDNA testing for detection of intravesical recurrence

  From randomization to 24 months.

• Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence

  From randomization to 24 months.

• Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence

  From randomization to 24 months.

Study Arms (2)

Arm A

EXPERIMENTAL

Participants will 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: utDNA testing + Urine Cytology

Arm B

ACTIVE COMPARATOR

Participants will undergo cystoscopy and urine cytology every 3 months. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

Diagnostic Test: Cystoscopy + Urine Cytology

Interventions

utDNA testing + Urine Cytology DIAGNOSTIC_TEST

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.

Arm A

Cystoscopy + Urine Cytology DIAGNOSTIC_TEST

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.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 years or older.
• Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.
• Prior to enrollment, participants must have undergone either:
• A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.

You may not qualify if:

• History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (2)

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

Guangzhou, China

NOT YET RECRUITING

The second hospital of Tianjin Medical University

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Hailong Hu, MD

CONTACT

+8613662096232; huhailong@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)