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

NCT ID: NCT04392076

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiofrequency Ablation (RFA) of RCC

Patients following image guided radiofrequency ablation (RFA) of renal cell carcinoma (RCC)

Image Guided Ablation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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Image Guided Ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Tze Min Wah

Consultant Radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tze Min Wah, PhD MBchB

Role: PRINCIPAL_INVESTIGATOR

Leeds Teaching Hospitals Trust

Locations

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Leeds Institute of Medical Research

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Anne Gowing

Role: CONTACT

01132433144 ext. 60483

Donna Johnstone

Role: CONTACT

01132433144 ext. 60469

Facility Contacts

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Roz Banks, PhD

Role: primary

0113 2064927

Tze Min Wah, PhD

Role: backup

0113 2066043

Other Identifiers

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124413

Identifier Type: -

Identifier Source: org_study_id

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