Image Guided RFA/MWA/CRYO of RCC Biomarker Profile Study

May 16, 2020 updated by: Tze Min Wah, University of Leeds

The Immune and Inflammatory Profile of Patients After Image Guided Ablation of Renal Cancer With Radiofrequency Ablation (RFA)/ Microwave Ablation (MWA) vs. Cryoablation (CRYO)

Often kidney cancer is diagnosed when the tumour is small and hasn't spread. Rather than major surgery to remove the whole kidney, image-guided ablation involving heat (microwave or radiofrequency) or freezing (cryotherapy) is often used to destroy the tumour using minimal invasive technique with much less risk and discomfort. Limited evidence suggests that ablation also activates the immune system which may help in fighting the cancer. We will investigate the immune and other changes by analysing blood samples from patients before and after ablation. Understanding this will help in designing more effective new treatments combining ablation with biological therapies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Image-guided ablation therapies are increasingly being used in renal and other cancers as an alternative to major surgery, particularly in the context of small localised masses or when patients have significant co-morbidities. Published analyses now also support the effectiveness of such treatments in terms of outcomes. Tumour ablation has been reported to generate immune and inflammatory responses following tumour destruction, essentially through release of tumour antigens in effect acting as a tumour "vaccine", resulting in systemic anti-tumour responses. Such studies are still limited but indicate possibilities in terms of combination therapies with immunotherapies and synergistic effects.

In order to take this forward in renal cancer it is now critical that studies are undertaken to explore further the immunobiological and inflammatory changes associated with ablation therapies. We propose to do this using a relatively new multiplex and highly sensitive proteomic biomarker array technology which allows the profiling of circulating proteins using arrays targeted at specific disease areas or processes. We have used this platform to generate some pilot data on RCC patients undergoing ablation to show feasibility and now propose to extend this further. The main benefits to patients will be in terms of understanding how the immune and inflammatory responses are affected by ablation which ultimately may lead to the design of new more effective therapeutic strategies combining ablation with immunotherapies. Ultimately more effective combination therapies would have health economic benefits and improved quality of life with potentially lower toxicity if the doses of the biological therapies could be reduced. Some of the protein changes may also act as surrogate markers of response and guide optimal treatment administration.

Study Type

Observational

Enrollment (Anticipated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds institute of Medical Research
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with RCC that are identified through renal cancer MDT and have agreed to undergo image guided ablation of RCC with thermal ablative technologies such as RFA, MWA or CRYO.

Description

Inclusion Criteria:

  1. Patients underwent image guided ablation for renal cell carcinoma (RCC) with heat-based energy (RFA/MWA) or ice-based energy (CRYO)
  2. No other prior treatment to RCC in either kidneys

Exclusion Criteria:

1. Patients with RCC that is not suitable for image guided ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiofrequency Ablation (RFA) of RCC
Patients following image guided radiofrequency ablation (RFA) of renal cell carcinoma (RCC)
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
Microwave Ablation (MWA) of RCC
Patients following image guided microwave ablation (MWA) of renal cell carcinoma (RCC)
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
Cryoablation (CRYO) of RCC
Patients following image guided cryoablation (CRYO) of renal cell carcinoma (RCC)
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the immune and inflammatory response to MWA/RFA and CRYO based on plasma protein profiling using multiplex arrays and how consistent the changes are between patients and treatment type.
Time Frame: 15 months
The data will be important in understanding how the immune and inflammatory responses are affected by ablation which ultimately may lead to the design of new more effective therapeutic strategies combining ablation with immunotherapies.
15 months
To analyse the profiles using biostatistical and bioinformatic tools to understand the immunopathological changes and understanding how such ablation therapies may be used in combination with immunotherapies for increased efficacy.
Time Frame: 15 months
The data will be important in understanding how the immune and inflammatory responses are affected by ablation which ultimately may lead to the design of new more effective therapeutic strategies combining ablation with immunotherapies.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tze Min Wah, PhD MBchB, Leeds Teaching Hospitals Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 16, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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