Image Guided RFA/MWA/CRYO of RCC Biomarker Profile Study
The Immune and Inflammatory Profile of Patients After Image Guided Ablation of Renal Cancer With Radiofrequency Ablation (RFA)/ Microwave Ablation (MWA) vs. Cryoablation (CRYO)
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS9 7TF
- Recruiting
- Leeds institute of Medical Research
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Contact:
- Roz Banks, PhD
- Phone Number: 0113 2064927
- Email: r.banks@leeds.ac.uk
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Contact:
- Tze Min Wah, PhD
- Phone Number: 0113 2066043
- Email: tze.wah@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients underwent image guided ablation for renal cell carcinoma (RCC) with heat-based energy (RFA/MWA) or ice-based energy (CRYO)
- 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
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)
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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)
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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)
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Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
|
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Tze Min Wah, PhD MBchB, Leeds Teaching Hospitals Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 124413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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