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Recruiting NCT07171554

NCT07171554 Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer

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Clinical Trial Summary
NCT ID NCT07171554
Status Recruiting
Phase
Sponsor Oncosyne AS
Condition Metastatic Colorectal Cancer (mCRC)
Study Type INTERVENTIONAL
Enrollment 75 participants
Start Date 2025-10-28
Primary Completion 2028-06

Trial Parameters

Condition Metastatic Colorectal Cancer (mCRC)
Sponsor Oncosyne AS
Study Type INTERVENTIONAL
Phase N/A
Enrollment 75
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-28
Completion 2028-06
Interventions
µCAN drug screen testStandard-of-Care Therapy

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. * Patient has the following laboratory values, as measured in serum/plasma within 14 days prior to signing of informed consent for participation in Part A and B, respectively, indicative of adequate organ function: * Haemoglobin at least 10.0 g/dL. * Neutrophils at least 1.5 x109/L (without current use of

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