Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
研究概览
简要总结
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
详细描述
The principle outcome of this study is to determine the negative predictive value (NPV) of finding no muscle invasive (pT2) tumor in seeT0 patients with a negative result on the ctDNA assay prior to radical cystectomy.
Eligible candidates for radical cystectomy and INSITE trial:
- Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy
- Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy
- cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.
After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.
Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Properly counselled patients with high grade T1 disease who elect for cystectomy
- •Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
- •cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
- •Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
- •Male or female patients age >=18 years at the time of consent.
- •Able and willing to comply with study requirements.
- •Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process.
- •Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
- •Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
排除标准
- •Patients who undergo cystectomy with non-curative intent will be excluded.
- •Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
- •Patients who are pregnant or nursing.
结局指标
主要结局
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
时间窗: 2 years
Determine the utility of a novel, proprietary combined blood and urinary genomic biomarker (ctDNA and cfDNA) assay in predicting the presence or absence of a muscle-invasive bladder cancer at cystectomy when no disease is identified on systematic endoscopic evaluation (SEE, aka seeT0).
Utility of a DNA test for muscle-invasive bladder cancer presence
时间窗: 2 years
Negative predictive value (NPV) of a negative ctDNA and urine-based cfDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy with a pre-surgical seeT0 bladder.
次要结局
- Accuracy of surgical specimen DNA test to predict muscle-invasive disease(2 years)
- Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence(2 years)