Kidney CancerPEAR-TREE2NCT06264479
Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
An observational study of Kidney Cancer and Renal Cell Cancer Metastatic, run by Ourotech, Inc. at 4 sites in United Kingdom.
Trial summary
Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Renal Cell Cancer Metastatic
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 19 Jun 2024to 25 Jul 2025
- 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 advanced or metastatic kidney cancer, due to start a new line of therapy
Who may be able to join
- Able to give written informed consent prior to admission to this study.
- Female or male aged ≥18 years.
- Evidence of advanced RCC with intention to receive systemic therapy, defined as:
- Clinical suspicion of advanced RCC with intention to undergo a clinically-mandated biopsy and subsequent systemic therapy OR
- Histological evidence of advanced RCC with intention to undergo subsequent systemic therapy and willing to undergo additional research biopsy
- At least one lesion evaluable under RECIST 1.1 criteria
- Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy.
- Willing to undergo venous sampling for 40mL of blood
Who cannot join
- Early stage kidney cancer
- Patients who do not have kidney cancer
- Patients with RCC that do not intend to receive systemic therapy
- Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
- Previous diagnosis of other cancer. Previously treated cancer may be acceptable in some circumstances (e.g. surgery for an unrelated cancer > 5 years ago) after discussion with the Sponsor.
- No lesions are amenable to biopsy
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Mount Vernon Cancer Centre
London, HA6 2RN
Imperial College Healthcare NHS Trust
London, W6 8RF
Royal Free NHS Foundation Trust
London
About this study
Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.
This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.
The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival).
Read the detailed description
This is a multicenter, international, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio test, in predicting response rate (ORR) in patients receiving standard of care systemic therapies for kidney cancer. Patients will undergo an additional, mandatory core needle biopsy of a lesion before commencing their next line of therapy. 40mL of blood will also be collected from each patient.
The biopsy sample will be run on the Pear Bio test while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio test will not be used to inform the choice of treatment and the treating oncologist will be blinded to the test results.
The investigators will measure objective response rate (ORR) and other outcome metrics (PFS, DoR, OS, etc.). The Pear Bio test results will be compared to the actual patient outcomes to determine the test's sensitivity, specificity, positive predictive value and negative predictive value.
- Conditions
- Kidney Cancer, Renal Cell Cancer Metastatic
- Being tested
- Biopsy
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker, immuno-oncology
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Patients undergo a biopsy from a lesion, and give 40ml of blood
| Study group | Role | What they receive |
|---|---|---|
| Trial Cohort | Patients with advanced or metastatic kidney cancer, due to start a new line of systemic therapy (targeted drug, immunotherapy, etc.) Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate correlation accuracy (sensitivity & specificity)
The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patient ORR (evaluated on imaging).
Measured: 6 months
Secondary outcomes (4)
Complete Response rate correlation accuracy (sensitivity & specificity)
The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a complete response (evaluated by imaging).
Measured: 2 years
Deep Response rate correlation accuracy (sensitivity & specificity)
The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a deep response (evaluated by imaging).
Measured: 2 years
Durable Response rate correlation accuracy (sensitivity & specificity)
The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a durable response at 6, 12 and 24 months (evaluated by imaging).
Measured: 2 years
PFS prediction accuracy
The performance of Pear image-based biomarkers are established against patients progression-free survival at 6, 12 and 24 months (evaluated by imaging).
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 posted20 Feb 2024
- Study start19 Jun 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ourotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, East & North Herts NHS Trust, Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ekaterini Boleti, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264479
- Sponsor's protocol ID
- PEAR-TREE2
- Acronym
- PEAR-TREE2
- Status last verified
- Jul 2025
- First submitted
- 9 Feb 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
- ClinicalTrials.gov ID
- NCT06264479
- Acronym / sponsor ID
- PEAR-TREE2 / PEAR-TREE2
- Conditions
- Kidney Cancer, Renal Cell Cancer Metastatic
- Keywords
- computer vision, cell culture, microtumor, functional testing, predictive biomarker, immuno-oncology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ourotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, East & North Herts NHS Trust, Imperial College Healthcare NHS Trust
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 20 Feb 2024 (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.
Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.
This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.
The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival).
Detailed description
This is a multicenter, international, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio test, in predicting response rate (ORR) in patients receiving standard of care systemic therapies for kidney cancer. Patients will undergo an additional, mandatory core needle biopsy of a lesion before commencing their next line of therapy. 40mL of blood will also be collected from each patient.
The biopsy sample will be run on the Pear Bio test while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio test will not be used to inform the choice of treatment and the treating oncologist will be blinded to the test results.
The investigators will measure objective response rate (ORR) and other outcome metrics (PFS, DoR, OS, etc.). The Pear Bio test results will be compared to the actual patient outcomes to determine the test's sensitivity, specificity, positive predictive value and negative predictive value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial Cohort | – | Procedure: BiopsyPatients with advanced or metastatic kidney cancer, due to start a new line of systemic therapy (targeted drug, immunotherapy, etc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced or metastatic kidney cancer, due to start a new line of therapy
Key inclusion criteria (8 listed)
- Able to give written informed consent prior to admission to this study.
- Female or male aged ≥18 years.
- Evidence of advanced RCC with intention to receive systemic therapy, defined as:
- At least one lesion evaluable under RECIST 1.1 criteria
- Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy.
Key exclusion criteria (7 listed)
- Early stage kidney cancer
- Patients who do not have kidney cancer
- Patients with RCC that do not intend to receive systemic therapy
- Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
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 |
|---|---|---|
| BiopsyPatients undergo a biopsy from a lesion, and give 40ml of blood | Procedure or surgery | Trial Cohort |
Primary outcome
Objective Response Rate correlation accuracy (sensitivity & specificity)
Time frame: 6 months
The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patient ORR (evaluated on imaging).
4 secondary outcomes
Complete Response rate correlation accuracy (sensitivity & specificity)
Time frame: 2 years
Deep Response rate correlation accuracy (sensitivity & specificity)
Time frame: 2 years
Durable Response rate correlation accuracy (sensitivity & specificity)
Time frame: 2 years
PFS prediction accuracy
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
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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.
Ekaterini Boleti principal investigator
Royal Free Hospital NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer and Renal Cell Cancer Metastatic, run by Ourotech, Inc. at 4 sites 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate correlation accuracy (sensitivity & specificity) (time frame: 6 months). 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 30 Jul 2025.