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)
1 other identifier
observational
43
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 19, 2020
May 1, 2020
1.6 years
May 14, 2020
May 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Radiofrequency Ablation (RFA) of RCC
Patients following image guided radiofrequency ablation (RFA) of renal cell carcinoma (RCC)
Microwave Ablation (MWA) of RCC
Patients following image guided microwave ablation (MWA) of renal cell carcinoma (RCC)
Cryoablation (CRYO) of RCC
Patients following image guided cryoablation (CRYO) of renal cell carcinoma (RCC)
Interventions
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \. Patients with RCC that is not suitable for image guided ablation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- The Leeds Teaching Hospitals NHS Trustcollaborator
Study Sites (1)
Leeds Institute of Medical Research
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Biospecimen
This is a prospective single-centre non-interventional study, collecting plasma and serum samples for immediate biomarker studies with residual samples stored for future research within an RTB.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tze Min Wah, PhD MBchB
Leeds Teaching Hospitals Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Radiologist
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 18, 2020
Study Start
June 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 19, 2020
Record last verified: 2020-05