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Trial Title:
Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
NCT ID:
NCT06264479
Condition:
Kidney Cancer
Renal Cell Cancer Metastatic
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Conditions: Keywords:
computer vision
cell culture
microtumor
functional testing
predictive biomarker
immuno-oncology
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Patients undergo a biopsy from a lesion, and give 40ml of blood
Arm group label:
Trial Cohort
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.
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.
Criteria for eligibility:
Study pop:
Patients with advanced or metastatic kidney cancer, due to start a new line of therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion:
1. Able to give written informed consent prior to admission to this study.
2. Female or male aged ≥18 years.
3. 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
4. At least one lesion evaluable under RECIST 1.1 criteria
5. Willing to donate at least two additional core biopsy samples prior to starting
subsequent systemic therapy.
6. Willing to undergo venous sampling for 40mL of blood
Exclusion:
1. Early stage kidney cancer
2. Patients who do not have kidney cancer
3. Patients with RCC that do not intend to receive systemic therapy
4. Patients who have already commenced systemic therapy with no plans of changing the
systemic therapy after the collection of the core needle biopsy.
5. 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.
6. 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.
7. No lesions are amenable to biopsy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Contact:
Last name:
Kate Fife
Facility:
Name:
Mount Vernon Cancer Centre
Address:
City:
London
Zip:
HA6 2RN
Country:
United Kingdom
Contact:
Last name:
Anand Sharma
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Facility:
Name:
Royal Free NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Contact:
Last name:
Ekaterini Boleti, MD PhD MRCP
Phone:
020 7830 2396
Phone ext:
34476
Start date:
May 1, 2024
Completion date:
March 31, 2029
Lead sponsor:
Agency:
Ourotech, Inc.
Agency class:
Industry
Collaborator:
Agency:
Royal Free Hospital NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Cambridge University Hospitals NHS Trust
Agency class:
Other
Collaborator:
Agency:
East & North Herts NHS Trust
Agency class:
Other
Collaborator:
Agency:
Imperial College Healthcare NHS Trust
Agency class:
Other
Source:
Ourotech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06264479
