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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03409224
Other study ID # 2009-6735
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 2003
Est. completion date April 2019

Study information

Verified date April 2021
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Outcome

Type Measure Description Time frame Safety issue
Primary Immune Response to Cryoablation, RFA and Laparoscopic Partial Nephrectomy The number of leukocytes found in the tissues cryoablation, radiofrequency ablation, or laparoscopic partial nephrectomy (control) 4 years