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

NCT07171554 | Recruiting

• 2 other identifiers: DSEE-CRC2024-519600-27-00
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

patient-derived tumoroids; in vitro diagnostics; drug screening; clinical performance study; randomized; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  Through completion of study Part A, an average of 6 months

Secondary Outcomes (4)

• Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks).

  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.

  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.

  Through completion of study Part A, an average of 6 months

• Frequency and nature of device deficiencies (DD).

  Through completion of study Part A, an average of 6 months

Study Arms (2)

µCAN guided therapy

EXPERIMENTAL

The treating physician may use the µCAN diagnostic drug screen report to guide therapy

Diagnostic Test: µCAN drug screen test

Standard-of-Care

OTHER

The patient will be given the Standard-of-Care in the 3rd line setting, trifluridine/tipiracil/bevacizumab

Other: Standard-of-Care Therapy

Interventions

µCAN drug screen test DIAGNOSTIC_TEST

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

µCAN guided therapy

Standard-of-Care Therapy OTHER

trifluridine/tipiracil/bevacizumab combination, 28 day cycles

Standard-of-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 colony-stimulating factors).
• Platelets at least 100 x109/L.
• AST/ALT no higher than 2xULN when patient does not have metastatic disease in the liver, or no higher than 5xULN when patient has metastatic disease in the liver.
• Bilirubin no higher than 1.5xULN when patient does not have metastatic disease in the liver, or no higher than 2xULN when patient has metastatic disease in the liver.
• Albumin no lower than 30 g/L.
• INR within normal level.
• Creatinine no higher than 1.5xULN.
• For Part A: the treating physician should follow contraceptive requirements described in the SmPC of respective treatment.
• For Part B: women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of \<1 % to prevent pregnancy from at least 2 weeks prior to the screening visit of Part B to 4 weeks after the last administration of IMP in Part B. In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom from the screening visit of Part B until 4 weeks after the last administration of IMP in Part B.
• The following are considered highly effective methods of contraception:

You may not qualify if:

• 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.
• Part B only: no µCAN report was generated from Part A.
• Part B only: Patient is not eligible for trifluridine/tipiracil/bevacizumab combination therapy.

Sponsors & Collaborators

• Oncosyne AS: lead
• University Hospital, Akershus: collaborator
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anne H Ree, MD, Professor of Oncology

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarle Bruun, PhD

CONTACT

+47 41234614; jarle@oncosyne.no

Peter W Eide, PhD

CONTACT

+47 98062623; peter@oncosyne.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 12, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)