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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
75
µCAN 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
trifluridine/tipiracil/bevacizumab combination, 28 day cycles
Akershus University Hospital
Lørenskog, Akershus, Norway
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)
Time frame: Through completion of study Part A, an average of 6 months
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)
Time frame: Through completion of study Part A, an average of 6 months
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).
Time frame: Through completion of study Part A, an average of 6 months
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).
Time frame: Through completion of study Part A, an average of 6 months
Frequency and nature of device deficiencies (DD).
To demonstrate compliance with the general safety and performance requirements for µCAN (Part A).
Time frame: Through completion of study Part A, an average of 6 months
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