Metastatic Colorectal Cancer (mCRC)DSEE-CRCNCT07171554
Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
A study testing µCAN drug screen test and Standard-of-Care Therapy in people with Metastatic Colorectal Cancer (mCRC), run by Oncosyne AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- µCAN drug screen test and Standard-of-Care Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- 28 Oct 2025to Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
- intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration. WOCBP with an exclusive male partner who has undergone vasectomy may chose not to use contraceptives.
- Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] >25 IU/L is confirmatory). Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 4 weeks after the last administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, Akershus, 1478
Anne H Ree, MD, Professor of Oncology, +47 48257968, a.h.ree@medisin.uio.no
Anne H Ree, MD, Professor of Oncology
About this study
Official title: Clinical Performance Study of a New Diagnostic Test for Drug Sensitivity Evaluation in Metastatic Colorectal Cancer
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)
- Being tested
- µCAN drug screen test, Standard-of-Care Therapy
- Keywords
- patient-derived tumoroids, in vitro diagnostics, drug screening, clinical performance study, randomized, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
µCAN drug screen testDiagnostic 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
Standard-of-Care TherapyOther
trifluridine/tipiracil/bevacizumab combination, 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| µCAN guided therapy | Experimental | The treating physician may use the µCAN diagnostic drug screen report to guide therapy Receives: 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 Receives: Other: Standard-of-Care Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Through completion of study Part A, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start28 Oct 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncosyne AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Akershus, CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Anne H Ree, MD, Professor of Oncology, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171554
- Sponsor's protocol ID
- DSEE-CRC
- Other IDs
- 2024-519600-27-00
- Acronym
- DSEE-CRC
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No