Differences in Immunologic Response to Cryoablation Versu... | NCT03409224

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

NCT03409224

Sponsor

University of California, Irvine

Status

Terminated

Last Update Posted

Apr 19, 2021Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Immune Response to 3 Approaches

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough participants

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Apr 2019Actual

Completion Date

Apr 2019Actual

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2021

Last Update Posted Date

Apr 19, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53Actual

Label	Type	Description	Intervention Names
Adults 18-99		Adults who are undergoing cryoablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Cryoablation
Partial Nephrectomy
Radiofrequency

Sampling Method

Probability Sample