Exploring the Use of Tumor Informed Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent of of tumor informed ctDNA test results on Signatera platform available
研究概览
简要总结
The study will evaluate the feasibility of collecting ctDNA data for UTUC patients in perioperative setting and if the data generated can help with design of future prospective trials for perioperative therapy in UTUC.
详细描述
This study will provide contemporary data for patients with UTUC in the perioperative setting that is unanticipated to become available through large interventional trials. Preliminary data from this study could inform future prospective trials aimed at intensifying or de-intensifying perioperative therapy in UTUC. The study will assess 1) the feasibility of obtaining tumor informed ctDNA on the Signatera platform in patients with High Grade Upper Tract Urothelial Cancer (HG UTUC) planned for systemic therapy and or surgical intervention, 2) if perioperative ctDNA dynamics in UTUC correlate with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery, and 3) if perioperative ctDNA dynamics in UTUC are prognostic for survival estimates as they are in muscle invasive bladder cancer (MIBC). Preliminary data from this study may also support clinical decisions of renal retention in patients treated with chemotherapy who chose to defer surgery.
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
- •HG UTUC patients planned for systemic therapy and or surgical intervention that will have ctDNA Signatera testing.
排除标准
- •UTUC patients without high grade disease that is not planned for either systemic therapy or surgical intervention and not planned to have ctDNA Signatera testing.
研究组 & 干预措施
High Grade (HG) Upper Tract Urothelial Cancer (UTUC)
Patients HG UTUC planned for systemic therapy and or surgical intervention will be recruited and have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting) at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy.
干预措施: Signatera testing (Diagnostic Test)
结局指标
主要结局
Percent of of tumor informed ctDNA test results on Signatera platform available
时间窗: until end of surveillance or adjuvant therapy, approximately 5 years
Percent of ctDNA results available at the protocol specified timepoints.
Correlation between perioperative ctDNA dynamics in UTUC with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery
时间窗: Up to approximately 5 years
Measured at or close to baseline, q4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy, approximately 5 years
Number of patients with ctDNA decline to zero and radiographic complete response after treatment
时间窗: until end of surveillance or adjuvant therapy, approximately 5 years
Number of patients with ctDNA decline to zero post-treatment with complete response per RECIST 1.1.
次要结局
未报告次要终点