Immune Response to 3 Approaches Clinical Trial
Official title:
Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma
| 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 |
| Verified date | April 2021 |
| Source | University of California, Irvine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Irvine |
| 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 |