Bladder Cancer, Cystoscopy, Liquid Biopsy
Conditions
Keywords
bladder cancer, liquid biopsy, cystoscopy, urine tumor DNA
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.
Interventions
DIAGNOSTIC_TESTutDNA 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_TESTCystoscopy + 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.
Sponsors
Tianjin Medical University Second Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female participants aged 18 years or older. 2. 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. 3. 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.
Exclusion criteria
1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | Up to 24 months from randomization. | Time from randomization to the first histologically confirmed intravesical tumor recurrence (any grade/stage). |
| Mean Number of Cystoscopic Examinations per Patient Within 2 Years | Up to 24 months from randomization. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 24 months from randomization. | Time from randomization to pathologic progression to muscle-invasive bladder cancer (≥T2), any newly diagnosed upper tract urothelial carcinoma (UTUC), distant metastasis from urothelial carcinoma, radical cystectomy or nephroureterectomy performed for oncologic progression, or urothelial carcinoma-specific death, whichever occurs first. |
| Sensitivity of serial utDNA testing for detection of intravesical recurrence | From randomization to 24 months. | Sensitivity is defined as the proportion of surveillance visits with histologically confirmed recurrence in which utDNA testing performed at the same visit is positive. |
| Specificity of serial utDNA testing for detection of intravesical recurrence | From randomization to 24 months. | Specificity is defined as the proportion of surveillance visits without recurrence in which utDNA testing is negative. |
| Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence | From randomization to 24 months. | Proportion of utDNA-positive surveillance visits with confirmed recurrence. |
| Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence | From randomization to 24 months. | Proportion of utDNA-negative surveillance visits without recurrence. |
| Patient-reported health-related quality of life measured by EQ-5D-5L | Up to 24 months from randomization. | Health-related quality of life (HRQoL) directly reported by patients without clinician interpretation, measured using the EQ-5D-5L questionnaire. |
| Patient-reported health-related quality of life measured by EORTC QLQ-C30 | Up to 24 months from randomization | Health-related quality of life directly reported by patients without clinician interpretation, assessed using the EORTC QLQ-C30 questionnaire. |
Countries
China
Contacts
CONTACTHailong Hu, MD
Outcome results
None listed