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

Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392076
• Other study ID #: 124413
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: University of Leeds
• Contact: Anne Gowing
• Phone: 01132433144
• Email: anne.gowing[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

Procedure:
• Image Guided Ablation
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer

Locations

Country	Name	City	State
United Kingdom	Leeds Institute of Medical Research	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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