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

Sponsor
University of California, Irvine (Other)
Overall Status
Terminated
CT.gov ID
NCT03409224
Collaborator
(none)
53
Enrollment
195
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2003
    Actual Primary Completion Date :
    Apr 1, 2019
    Actual Study Completion Date :
    Apr 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Adults 18-99

    Adults who are undergoing cryoablation

    Outcome Measures

    Primary Outcome Measures

    1. Immune Response to Cryoablation, RFA and Laparoscopic Partial Nephrectomy [4 years]

      The number of leukocytes found in the tissues cryoablation, radiofrequency ablation, or laparoscopic partial nephrectomy (control)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of California, Irvine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Irvine
    ClinicalTrials.gov Identifier:
    NCT03409224
    Other Study ID Numbers:
    • 2009-6735
    First Posted:
    Jan 24, 2018
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Apr 19, 2021