T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
研究概览
简要总结
T1G3 bladder cancer is a heterogeneous disease with a high risk of disease persistence after the first TUR-B, understaging, disease progression, bladder removal, and mortality.
Current risk stratification is insufficient and needs improvement. Ct-DNA could identify patients with disease persistence, progression and could monitor and tailor therapy. It might improve patient risk stratification, avoiding under- and overtreatment, reducing morbidity and mortality.
Primary objective is to investigate the detectability of ct-DNA in T1G3 urothelial bladder cancer patients and build a biobank through collection of different sample types (urine, plasma) in T1G3 bladder cancer patients which allows future retrospective testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •patients > 18 years of age, able to give informed consent as documented by signature,
- •patients with a cystoscopically proven bladder cancer, suspicious for T1 stage, who will undergo TUR-B
排除标准
- •Patients with metastases or concomitant upper tract tumor at diagnosis will
- •Patients with non T1 G3 cancers
- •Patients with upstaging, either at re-TUR-B or after immediate radical cystectomy
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Vulnerable persons (e.g. < 18y of age, unable to consent to the study)
