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

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ClinicalTrials.gov 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
Sponsor:
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


Group/Cohort
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
Criteria

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
ClinicalTrials.gov 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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases