NCT02143492

Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Argos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer
• Renal Cell Carcinoma
• Advanced Renal Cell Carcinoma

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-05-21
• Last updated: 2017-01-24

Locations

5 sites across 1 country: United States