Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

NCT02143492 | Completed

• 1 other identifier: AGS-NTS-020
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 5

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.

Conditions

Kidney Cancer; Renal Cell Carcinoma; Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor Specimen

  Tumor specimen collection

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with advanced renal cell carcinoma (kidney cancer)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (5)

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Marietta, Georgia, 30060, United States

Location

Unknown Facility

Woodbury, Minnesota, 55125, United States

Location

Unknown Facility

Rock Hill, North Carolina, 29732, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Excess kidney cancer tumor specimen

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Neal Shore, MD, FACP

  Carolina Urologic Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 21, 2014
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)