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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Up to 24 months from randomization. |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailong Hu, MD | Contact | +8613662096232 | huhailong@tmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingtai People's Hospital | Recruiting | Xingtai | Hebei | China |
Individual participant data will not be shared due to patient privacy concerns and institutional restrictions.
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|
| 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. |
|
| Sensitivity of serial utDNA testing for detection of intravesical recurrence | Sensitivity is defined as the proportion of surveillance visits with histologically confirmed recurrence in which utDNA testing performed at the same visit is positive. | From randomization to 24 months. |
| Specificity of serial utDNA testing for detection of intravesical recurrence | Specificity is defined as the proportion of surveillance visits without recurrence in which utDNA testing is negative. | From randomization to 24 months. |
| Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence | Proportion of utDNA-positive surveillance visits with confirmed recurrence. | From randomization to 24 months. |
| Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence | Proportion of utDNA-negative surveillance visits without recurrence. | From randomization to 24 months. |
| Patient-reported health-related quality of life measured by EQ-5D-5L | Health-related quality of life (HRQoL) directly reported by patients without clinician interpretation, measured using the EQ-5D-5L questionnaire. | Up to 24 months from randomization. |
| Patient-reported health-related quality of life measured by EORTC QLQ-C30 | Health-related quality of life directly reported by patients without clinician interpretation, assessed using the EORTC QLQ-C30 questionnaire. | Up to 24 months from randomization |
| Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital of Harbin Medical University | Recruiting | Haerbin | China |
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| The Second Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | China |
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| Nanchang Second People's Hospital | Recruiting | Nanchang | China |
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| The second hospital of Tianjin Medical University | Recruiting | Tianjin | 300000 | China |
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| General Hospital of Tianjin Medical University | Recruiting | Tianjin | China |
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| Tianjin Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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