KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- ctDNA can identify high risk patients
研究概览
简要总结
The overall aim of this observational study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for renal cell carcinoma (RCC) can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
详细描述
OBJECTIVES
The overall objective of the study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for RCC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
1.1 Primary objectives
- To confirm that patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after nephrectomy.
Specifically, we aim to determine in patients with localized RCC (stages I-III) if the three-year disease-free survival is associated with detection of ctDNA in plasma immediately after 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
- •Patients diagnosed with a locoregional cancer in the kidney, and with a tumour available for surgical excision, and sufficient performance status for surgery.
- •Patients with M1 disease, but no evidence of disease after surgery and local treatment of the metastases.
- •Core needle biopsy-proven renal cell carcinoma - all histologic subtypes acceptable, clinical tumour stage I-IV
- •Patients 18 years or older
- •Patients able to understand and sign written informed consent
- •Scheduled for curative intent resectional surgery (partial or radical nephrectomy)
排除标准
- •Patients with local disease who are not being offered a nephrectomy.
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study
结局指标
主要结局
ctDNA can identify high risk patients
时间窗: baseline, 1 year, 2 year and 3 year
ctDNA will be determined and levels will be measured, and correlated to relapse status, progression free survival, treatment response and overall survival
次要结局
未报告次要终点