Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

Renal Cell Carcinoma Clinical Trial

Official title:

Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143492
• Other study ID #: AGS-NTS-020
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: January 23, 2017
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Argos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Age = 18 years

• 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A)

• 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy

• 4. 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

Exclusion Criteria:

• 1. Evidence of brain metastases prior to nephrectomy

• 2. 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.)

• 3. History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Argos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Specimen	Tumor specimen collection	5 years