Clinical trial NCT02143492: Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC
Official title: Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
Lead sponsor: Argos Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with advanced renal cell carcinoma (kidney cancer)

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Specimen
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
state: Colorado
city: Marietta
country: United States
state: Georgia
city: Woodbury
country: United States
state: Minnesota
city: Rock Hill
country: United States
state: North Carolina
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Carolina Urologic Research Center
name: Neal Shore, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: