Understanding the usefulness of the PEAR-BIO platform in patients with kidney cancer
| ISRCTN | ISRCTN10001405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10001405 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 312529 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 312529, CPMS 52231 |
- Submission date
- 19/08/2022
- Registration date
- 14/10/2022
- Last edited
- 01/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Kidney cancer represents a major unmet healthcare need. There is a range of treatments that are available for patients with kidney cancer, although it can be difficult to know which treatment is best for different patients.
We have developed a novel platform that uses a sample of a patient's tumour to directly test different drugs and try and predict which drug(s) might work best for different patients. The first step in this process is to assess the correct dose of different treatments on our platform.
This study aims to use tissue on our platform from patients with kidney cancer who are having surgery to assess the correct dose of each of the drugs for use in our system. Our secondary objectives are around checking to see how these correlate with existing biomarkers.
Who can participate?
Adult patients with operable kidney cancer who are undergoing surgery, and are able to donate 40 ml of blood
What does the study involve?
Patients provide informed consent and have surgery as normal, as well as providing a 40 ml blood sample.
What are the possible benefits and risks of participating?
There are no direct benefits from participation, other than helping to develop a test that might help predict treatment response in the future, and the general increase in scientific knowledge. There should be no additional risks. Patients will have surgery as planned, and the donation of 40 ml of blood should pose no additional risk.
Where is the study run from?
The Royal Free Hospital NHS Foundation Trust (United Kingdom)
When is the study starting and how long is it expected to run for?
February 2022 to March 2023
Who is funding the study?
Pear Bio (United Kingdom)
Who is the main contact?
1. Prof. Maxine Tran (Principal investigator) (United Kingdom)
m.tran@ucl.ac.uk
2. Dr. Matthew Williams (Medical Director) (United Kingdom)
Matthew@pearbio.Com
Contact information
Principal Investigator
Division of Surgery and Interventional Science
9th Floor
Royal Free Hospital Campus
Rowland Street
London
NW3 2QG
United Kingdom
 ORCID ID |
0000-0002-6034-4433 |
|---|---|
| Phone | +44 (0)208 0168121 |
| m.tran@ucl.ac.uk |
Study information
| Study design | Observational single-centre non-randomized trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 42259 PEAR-TREE PIS v1.1 20220303.pdf |
| Scientific title | Prospective Evaluation of AI R&D tool for patient stratification - Trial for Renal immuno-oncology model Experimental Evaluation (PEAR-TREE) |
| Study acronym | PEAR-TREE |
| Study hypothesis | We have developed a new AI-enabled, tissue-sample-based platform to provide a functional precision medicine approach. This study will apply the platform to renal cancer, with a particular focus on immunotherapy drugs. Our main aim is to establish the correct dose of FDA-approved therapies in renal cell carcinoma in our model. Secondary objectives include understanding the correlation between biomarkers and response in our system. |
| Ethics approval(s) | Approved 03/03/2022, Yorkshire & The Humber - Bradford Leeds REC (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle Upon Tyne, Tyne and Wear, NE2 4NQ, United Kingdom; +44 (0)207 104 8083; bradfordleeds.rec@hra.nhs.uk), ref: 22/YH/0068 |
| Condition | Patients undergoing surgery for renal cell carcinoma |
| Intervention | Patients will undergo surgery as standard. We will use tissue from surgery, combined with a blood sample, and take these to the lab. The tissue will be split into multiple samples, and then tested on our platform. We grow the cells in multiple different wells, using one as a control, and test various drugs and immunotherapy agents in the other wells. We then image the wells on days 0, 1, 2, 3 and 4 and report the extent of cell viability, migration and activation and invasion of immune cells. Drugs being tested alone or in combination include: 1. Ipilimumab + nivolumab 2. Axitinib + pembrolizumab 3. Cabozantinib + nivolumab 4. Lenvatinib + pembrolizumab 5. Pazopanib 6. Sunitinib 7. Sorafenib 8. Everolimus 9. Sapanisertib |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, lenvatinib, pazopanib, sunitinib, sorafenib, everolimus, sapanisertib |
| Primary outcome measure | Assessment of the functional dose of FDA-approved drugs for renal cell carcinoma and confirmation of mechanism of action, both intra- and inter-patient variation, measured using cell alive/dead ratio in an ex-vivo assay at days 0 - 5 time points |
| Secondary outcome measures | Assess the correlation of biomarkers to ex vivo tumour response via multi-omics analyses. Biomarkers include gene and protein expression (using RNASeq and ELISA) measured against ex-vivo response, which includes measures of cell alive/dead ratios, invasion and migration, and immune cell infiltration at days 0 - 5 timepoints: 1. The relationship between biomarkers and ex vivo response 2. Ordinal regression correlating biomarker response against ex vivo treatment sensitivity/ resistance |
| Overall study start date | 01/02/2022 |
| Overall study end date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Aged 18 years old and over 2. Patients with operable kidney cancer 3. Able to give informed consent 4. Able to give 40 ml of blood and surgical sample yields >= 0.4 g of cancerous tissue |
| Participant exclusion criteria | 1. Inoperable or metastatic kidney cancer 2. Pre-operative haemoglobin levels below 120g/l 3. Patients who have already commenced chemotherapy, targeted therapy, immunotherapy or radiotherapy 4. Recurrence of cancer from any other site than the kidney 5. Any other disease or finding that renders the patient at high risk of treatment complications or interferes with obtaining informed consent |
| Recruitment start date | 01/10/2022 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pond Street
London
NW3 2QG
United Kingdom
Sponsor information
Industry
Camburgh House
27 New Dover Road
Canterbury
Kent
Canterbury
CT1 3DN
England
United Kingdom
| Phone | + (0)7716558079 |
|---|---|
| duleek@pearbio.com | |
| Website | https://www.pearbio.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed journal 2. Conferences 3. Company website |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because these data are from confocal microscopy on our platform, and as such are not interpretable by external users |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 03/03/2022 | 28/09/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
01/11/2022: Internal review.
28/09/2022: Trial's existence confirmed by HRA and Health and Care Research Wales (HCRW)
