Renal CancerNCT04392076
Image Guided RFA/MWA/CRYO of RCC Biomarker Profile Study
An observational study of Renal Cancer, run by University of Leeds at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Image Guided Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 1. Patients with RCC that is not suitable for image guided ablation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Institute of Medical Research
Leeds, West Yorkshire, LS9 7TF
Roz Banks, PhD, 0113 2064927, r.banks@leeds.ac.uk
Tze Min Wah, PhD, 0113 2066043, tze.wah@nhs.net
About this study
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)
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.
Read the 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.
- Conditions
- Renal Cancer
- Being tested
- Image Guided Ablation
- Keywords
- Radiofrequency ablation (RFA), Microwave ablation (MWA), Cryoablation (CRYO), Biomarker
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image Guided AblationProcedure or surgery
Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation (RFA) of RCC | Patients following image guided radiofrequency ablation (RFA) of renal cell carcinoma (RCC) Receives: Procedure: Image Guided Ablation | |
| Microwave Ablation (MWA) of RCC | Patients following image guided microwave ablation (MWA) of renal cell carcinoma (RCC) Receives: Procedure: Image Guided Ablation | |
| Cryoablation (CRYO) of RCC | Patients following image guided cryoablation (CRYO) of renal cell carcinoma (RCC) Receives: Procedure: Image Guided Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Tze Min Wah, University of Leeds
- Investigators
- Tze Min Wah, PhD MBchB, Principal investigator, Leeds Teaching Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392076
- Sponsor's protocol ID
- 124413
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04392076
- Acronym / sponsor ID
- 124413
- Conditions
- Renal Cancer
- Keywords
- Radiofrequency ablation (RFA), Microwave ablation (MWA), Cryoablation (CRYO), Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation (RFA) of RCC | – | Procedure: Image Guided AblationPatients following image guided radiofrequency ablation (RFA) of renal cell carcinoma (RCC) |
| Microwave Ablation (MWA) of RCC | – | Procedure: Image Guided AblationPatients following image guided microwave ablation (MWA) of renal cell carcinoma (RCC) |
| Cryoablation (CRYO) of RCC | – | Procedure: Image Guided AblationPatients following image guided cryoablation (CRYO) of renal cell carcinoma (RCC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients with RCC that is not suitable for image guided ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image Guided AblationImage Guided Ablation with RFA, MWA or CRYO of Renal Cancer | Procedure or surgery | Cryoablation (CRYO) of RCC, Microwave Ablation (MWA) of RCC, Radiofrequency Ablation (RFA) of RCC |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Min Wah, PhD MBchB principal investigator
Leeds Teaching Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Gowing (01132433144 ext. 60483, anne.gowing@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.