Carcinoma, Renal CellARTIST_RCCNCT04060537
Identification of Novel Biomarkers of Response to Systemic Treatments in Renal Cell Cancer
An observational study of Carcinoma, Renal Cell, run by CCTU- Cancer Theme.
Trial summary
This research study aims to investigate changes inside kidney cancers (also known as Renal Cell Carcinoma or RCC), and in normal kidney surrounding the tumour, when patients are treated with systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Laboratory analysis of samples and Application of machine learning
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2022
- 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: Participants with renal cell cancer who have given prior consent under NeoSUN for their samples and data to be used, and who have adequate samples and data available.
Who may be able to join
- Aged 18 years or older
- Diagnosis of renal cell cancer (any stage).
- Patient received systemic treatment for their renal cancer at Cambridge University Hospitals NHS Foundation Trust.
- Patients must have consent in place, for the use of tissue and imaging to be used for the purposes of clinical research;
- Use of tissue not required for their diagnosis or treatment to be stored and used for the purposes of clinical research, which may include genetic research.
- Use of relevant sections of their medical records, or by relevant regulatory authorities, where my tissue is being used for research, giving permission for those individuals to have access to their medical records.
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- Participants must also meet at least one of the following criteria to be eligible:
- For tissue analysis: Patient must have tumour tissue and/or normal adjacent kidney stored (either as formalinfixed paraffin-embedded tissue, or as 'fresh frozen' tissue).
- For imaging analysis: Patient must have had at least 1 scan (either CT or MRI) within 28 days of starting treatment with systemic treatment for their cancer.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Translational Study to Identify Novel Biomarkers of Response to Systemic Treatments in Renal Cell Cancer
This research study aims to investigate changes inside kidney cancers (also known as Renal Cell Carcinoma or RCC), and in normal kidney surrounding the tumour, when patients are treated with systemic therapy.
Samples, radiological images and data from a previous trial (NeoSUN) will be analysed and/or reanalysed, in accordance with the consent of NeoSUN participants.
Read the detailed description
This research study aims to investigate changes inside kidney cancers, and in normal kidney surrounding the tumour, when patients are treated with systemic therapy. Systemic treatment is widely used as routine treatment for patients who have kidney cancer that has spread to other organs. It is also used sometimes before surgery to try to shrink kidney cancers to make surgery easier and less risky. Recent research has shown that kidney cancers consist of many different cells in addition to the cancer cells (including immune, structural and blood vessel cells). However, doctors know very little about what changes systemic therapy causes to cells other than cancer cells.
Researchers now think that these other cells may influence how the tumour cells behave during cancer treatment and how well the cancer responds to treatment.
The NeoSUN clinical trial was run at Cambridge University Hospitals between 2006 and 2015.18 patients were treated with a TKI called sunitinib for 12 days before they had their kidney surgically removed. MRI and CT scans were performed before and after the treatment. Samples of tumour and normal kidney were also taken before and after treatment. All patients consented to use of their tissue and data for future research projects. The investigators would like to analyse the effects that sunitinib had on the tumour and other cells using techniques called immunohistochemistry, immunofluorescence, and CyTOF. These mark the different cells so they can easily be identified and the effects on each one analysed. The investigators would also like to re-analyse the scans performed and use artificial intelligence (AI) to see try to detect new trends. The information may help to guide which drugs might be best used in future to treat kidney cancer more effectively whilst keeping side effects low.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Laboratory analysis of samples, Application of machine learning
- Keywords
- Cancer, Renal, Tyrosine Kinase Inhibitors, Systemic Treatments, Biomarkers
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory analysis of samplesOther
RNA sequencing, immunohistochemistry, immunofluorescence, and cytometry of tumour tissues
Application of machine learningOther
Using machine learning to interrogate data generated from analysis of Renal Cell Cancer tumours using RNA sequencing, immunohistochemistry, immunofluorescence, cytometry, and MRI imaging of tumours.
| Study group | Role | What they receive |
|---|---|---|
| Research | Patients with Renal Cell Carcinoma who have had previous systemic treatment, with adequate tissue samples and radiological data Receives: Other: Laboratory analysis of samples; Other: Application of machine learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Using data from RNA sequencing of tumour tissues, the outcome is to identify novel biomarkers of response.
Measured: 2 years
Radiological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Using data from MRI imaging by analysis of the tumour microenvironment and machine learning interrogation of output data, the outcome is to identify novel biomarkers of response.
Measured: 2 years
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Using data from immunohistochemistry, the outcome is to identify novel biomarkers of response.
Measured: 2 years
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Using data from immunofluorescence, the outcome is to identify novel biomarkers of response.
Measured: 2 years
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Using data from CyTOF (mass cytometry), the outcome is to identify novel biomarkers of response.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Sarah Welsh, Principal investigator, Cambridge University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060537
- Sponsor's protocol ID
- ARTIST RCC
- Acronym
- ARTIST_RCC
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Translational Study to Identify Novel Biomarkers of Response to Systemic Treatments in Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT04060537
- Acronym / sponsor ID
- ARTIST_RCC / ARTIST RCC
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Cancer, Renal, Tyrosine Kinase Inhibitors, Systemic Treatments, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 19 Aug 2019 (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.
This research study aims to investigate changes inside kidney cancers (also known as Renal Cell Carcinoma or RCC), and in normal kidney surrounding the tumour, when patients are treated with systemic therapy.
Samples, radiological images and data from a previous trial (NeoSUN) will be analysed and/or reanalysed, in accordance with the consent of NeoSUN participants.
Detailed description
This research study aims to investigate changes inside kidney cancers, and in normal kidney surrounding the tumour, when patients are treated with systemic therapy. Systemic treatment is widely used as routine treatment for patients who have kidney cancer that has spread to other organs. It is also used sometimes before surgery to try to shrink kidney cancers to make surgery easier and less risky. Recent research has shown that kidney cancers consist of many different cells in addition to the cancer cells (including immune, structural and blood vessel cells). However, doctors know very little about what changes systemic therapy causes to cells other than cancer cells.
Researchers now think that these other cells may influence how the tumour cells behave during cancer treatment and how well the cancer responds to treatment.
The NeoSUN clinical trial was run at Cambridge University Hospitals between 2006 and 2015.18 patients were treated with a TKI called sunitinib for 12 days before they had their kidney surgically removed. MRI and CT scans were performed before and after the treatment. Samples of tumour and normal kidney were also taken before and after treatment. All patients consented to use of their tissue and data for future research projects. The investigators would like to analyse the effects that sunitinib had on the tumour and other cells using techniques called immunohistochemistry, immunofluorescence, and CyTOF. These mark the different cells so they can easily be identified and the effects on each one analysed. The investigators would also like to re-analyse the scans performed and use artificial intelligence (AI) to see try to detect new trends. The information may help to guide which drugs might be best used in future to treat kidney cancer more effectively whilst keeping side effects low.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research | – | Other: Laboratory analysis of samples, Other: Application of machine learningPatients with Renal Cell Carcinoma who have had previous systemic treatment, with adequate tissue samples and radiological data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with renal cell cancer who have given prior consent under NeoSUN for their samples and data to be used, and who have adequate samples and data available.
Key inclusion criteria (9 listed)
- Aged 18 years or older
- Diagnosis of renal cell cancer (any stage).
- Patient received systemic treatment for their renal cancer at Cambridge University Hospitals NHS Foundation Trust.
- Patients must have consent in place, for the use of tissue and imaging to be used for the purposes of clinical research;
- Participants must also meet at least one of the following criteria to be eligible:
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Laboratory analysis of samplesRNA sequencing, immunohistochemistry, immunofluorescence, and cytometry of tumour tissues | Other | Research |
| Application of machine learningUsing machine learning to interrogate data generated from analysis of Renal Cell Cancer tumours using RNA sequencing, immunohistochemistry, immunofluorescence, cytometry, and MRI imaging of tumours. | Other | Research |
Primary outcome
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Time frame: 2 years
Using data from RNA sequencing of tumour tissues, the outcome is to identify novel biomarkers of response.
Radiological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Time frame: 2 years
Using data from MRI imaging by analysis of the tumour microenvironment and machine learning interrogation of output data, the outcome is to identify novel biomarkers of response.
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Time frame: 2 years
Using data from immunohistochemistry, the outcome is to identify novel biomarkers of response.
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Time frame: 2 years
Using data from immunofluorescence, the outcome is to identify novel biomarkers of response.
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.
Time frame: 2 years
Using data from CyTOF (mass cytometry), the outcome is to identify novel biomarkers of response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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.
Sarah Welsh principal investigator
Cambridge University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by CCTU- Cancer Theme.
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 9 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Richard Skells (01223348454, richard.skells@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. (time frame: 2 years). The study lists 5 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 Aug 2019.