DSEE-CRC is a top-tier Norwegian and Swedish public-private partnership for the development of µCAN, a unique patient-centric, therapy-guiding in vitro diagnostic test to improve cancer treatment outcomes for metastatic colorectal cancer patients. µCAN takes a cancer biopsy sample as input and combines proprietary patient-derived tumoroid culturing conditions with state of-the-art machine learning, and computer-vision guided fluorescence high- content drug screening and analysis, to identify the best therapeutical approach for clinical practice. DSEE-CRC will have a positive societal and financial impact and directly contributes to the Good Health and Well-being Sustainable Development Goals by delivering patient-tailored treatments, concurrently increasing cancer survivability rates, improving patients' quality of care, and reducing cancer treatment costs for healthcare providers.
Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.
Male or female patients, ≥18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, who have metastatic lesions in the liver or peritoneum (or lymph nodes) that are radiologically assessable and can be biopsied, and who have recently failed 1st line systemic therapy (2nd line for patients with three standard therapy lines) for unresectable metastatic disease and will shortly commence a new line of standard therapy.
Patient is eligible for another line of tumour directed therapy on failure of the SoC.
Haemoglobin at least 10.0 g/dL.
Life expectancy < 3 months.
Planned treatment or treatment with another investigational drug or investigational device within 3 months prior to the day of the tumour sampling procedure.
Patients who are pregnant, or currently breastfeeding.
Investigator considers the patient unlikely to comply with clinical performance study procedures, restrictions and requirements.
Parallel
µCAN drug screen test
Diagnostic testµCAN guided therapy is based on drug screening of patient-derived tumoroids. The patient might be treated with clinically relevant on-label or off-label drugs
Standard-of-Care Therapy
Other interventiontrifluridine/tipiracil/bevacizumab combination, 28 day cycles
Proportion of patients with a successful biopsy yielding a µCAN report.
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician's choice for 3rd line therapy for patients with mCRC (Part A)
Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks).
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician's choice for 3rd line therapy for patients with mCRC (Part A)
Proportion of patients with a successful biopsy yielding a µCAN report with at least one drug therapy nomination.
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician's choice for 3rd line therapy for patients with mCRC (Part A).
Frequency, intensity and seriousness of adverse events (AEs) related to device or study procedures.
To demonstrate compliance with the general safety and performance requirements for µCAN (Part A).
Frequency and nature of device deficiencies (DD).
To demonstrate compliance with the general safety and performance requirements for µCAN (Part A).
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NorwayClick on the lead sponsor to view all of their trials.
Oncosyne AS
Lead sponsor
University Hospital, Akershus
Collaborator
CTC Clinical Trial Consultants AB
Collaborator
