Actively Recruiting
Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
Led by Oncosyne AS · Updated on 2026-04-30
75
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
O
Oncosyne AS
Lead Sponsor
U
University Hospital, Akershus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent for participation
- Male or female patients 18 years or older with metastatic colorectal cancer lesions in liver, peritoneum, or lymph nodes that can be biopsied
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Recently failed first-line systemic therapy (or second-line for patients with three standard therapy lines) for unresectable metastatic disease and will start a new line of standard therapy
- Eligible for another line of tumor-directed therapy after failure of standard-of-care
- Adequate organ function based on recent laboratory values: haemoglobin at least 10.0 g/dL; neutrophils at least 1.5 x10^9/L without colony-stimulating factors; platelets at least 100 x10^9/L; AST/ALT no higher than 2xULN without liver metastases or no higher than 5xULN with liver metastases; bilirubin no higher than 1.5xULN without liver metastases or no higher than 2xULN with liver metastases; albumin no lower than 30 g/L; INR normal; creatinine no higher than 1.5xULN
- For Part A: follow contraceptive requirements described in SmPC of respective treatment
- For Part B: women of childbearing potential must either practice abstinence or use highly effective contraception from 2 weeks before screening through 4 weeks after last IMP administration; male partners must use condoms unless vasectomized
- Women of non-childbearing potential defined by surgical history or menopausal status
- Male participants must use condoms, be vasectomized, or practice sexual abstinence to prevent pregnancy and refrain from sperm donation during IMP administration period
- Female partners of non-vasectomized male participants of childbearing potential must use contraception from 2 weeks before first IMP administration through 4 weeks after last IMP administration
You will not qualify if you...
- Life expectancy less than 3 months
- Planned or current treatment with another investigational drug or device within 3 months before tumor sampling
- Pregnant or breastfeeding
- Investigator considers patient unlikely to comply with study procedures and requirements
- For Part B only: no CAN report generated from Part A
- For Part B only: patient not eligible for trifluridine/tipiracil/bevacizumab combination therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Actively Recruiting
Research Team
J
Jarle Bruun, PhD
CONTACT
P
Peter W Eide, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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