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Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03409224
Recruitment Status : Unknown
Verified October 2018 by Jaime Landman, University of California, Irvine.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : October 11, 2018
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine

Brief Summary:
The purpose of this study is to compare changes in the body's self-defense (immune response) after two different treatments for small kidney tumors: 1) Cryoablation (freezing) therapy in which the tumor and a margin of normal kidney tissue are frozen and thawed twice with a needle probe and 2) radiofrequency ablation (RFA) in which radiofrequency energy delivered through a needle probe is used to heat tissue and thereby destroy a tumor.

Condition or disease
Immune Response to 3 Approaches

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma
Study Start Date : January 2003
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Adults 18-99
Adults who are undergoing cryoablation

Primary Outcome Measures :
  1. Immune Response to Cryoablation, RFA and Laparoscopic Partial Nephrectomy [ Time Frame: 4 years ]
    The number of leukocytes found in the tissues cryoablation, radiofrequency ablation, or laparoscopic partial nephrectomy (control)

Biospecimen Retention:   Samples With DNA
Small cancer tissue samples were collected post ablation therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients that undergo one of the three treatments for Renal Masses:

  • Cryoablation
  • Partial Nephrectomy
  • Radiofrequency

Inclusion Criteria:

  • You are eligible to participate in this study if you are an adult (older than 18 years)
  • Diagnosed with renal cell cancer 1-3 centimeters in size on the CT scan.

Exclusion Criteria:

  • You are not eligible to participate in this study if you are immune compromised (chemotherapy,corticosteroid use, HIV [as documented in your medical record], etc.)
  • Have an autoimmune disorders (Rheumatoid arthritis, Crohn's disease, etc)
  • Have a tumor larger than 4 cm
  • Are pregnant.
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Responsible Party: Jaime Landman, Professor and Chairman, University of California, Irvine Identifier: NCT03409224    
Other Study ID Numbers: 2009-6735
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases