The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 8
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A
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.
干预措施: utDNA testing + Urine Cytology (Diagnostic Test)
Arm B
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.
干预措施: Cystoscopy + Urine Cytology (Diagnostic Test)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: 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
时间窗: 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.
次要结局
- Progression-Free Survival (PFS)(Up to 24 months from randomization.)
- Progression-Free Survival (PFS)(Up to 24 months from randomization.)
- Diagnostic/Prognostic Performance of utDNA(From randomization to 24 months.)
- 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.)
- Patient-reported health-related quality of life measured by EQ-5D-5L(Up to 24 months from randomization.)
- Patient-reported health-related quality of life measured by EORTC QLQ-C30(Up to 24 months from randomization)