Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 主要终点
- Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
研究概览
简要总结
In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals. The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC histology, other renal masses, and after surgery. Finally, the investigators estimated whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with radiographic finding of renal mass referred to primary surgery;
- •Healthy volunteers without any history of malignancy.
排除标准
- •No records on date of surgery;
- •A pre-operative sample was obtained 50 days or earlier with respect to the date of surgery; - Absence of pre-operative samples following filtering out outliers or laboratory assay failures.
结局指标
主要结局
Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
时间窗: 1 month
次要结局
- Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC(1 month)
- Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.(1 month)
- Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC(1 month)
- Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC(53 months)
- Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for metastatic recurrence-free survival in RCC(53 months)
- Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm(1 month)