Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 主要终点
- Tumor Specimen
研究概览
简要总结
Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery.
详细描述
The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and store excess tumor specimens, which would otherwise be discarded, following routine nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor specimen will be preserved under current Good Manufacturing Practice conditions and will not be used for any other research or therapeutic purpose without a separate consent from the subject, specific to the intended use on a separate Institutional Review Board or Institutional Ethics Committee approved Argos sponsored study.
Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA preservative solution as supplied by the sponsor. After collection, this preserved tumor specimen will be shipped to a repository operating under current Good Manufacturing Practice conditions. The tumor specimen will be stored for no longer than five years unless subsequent consent is obtained for extended storage or other use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥ 18 years
- •Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A)
- •Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy
- •Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of tumor specimen collection prior to enrollment
排除标准
- •Evidence of brain metastases prior to nephrectomy
- •Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
- •History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C
结局指标
主要结局
Tumor Specimen
时间窗: 5 years
Tumor specimen collection
次要结局
未报告次要终点