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临床试验/NCT02923284
NCT02923284已完成不适用

Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
407
试验地点
1
主要终点
Urine AQP1

研究概览

简要总结

The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.

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

入选标准

  • Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),

排除标准

  • Age <18 years and prisoners.

结局指标

主要结局

Urine AQP1

时间窗: 28 days

Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.

PLIN2 concentration

时间窗: 28 days

Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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