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New treatment option for Metastatic Colorectal Cancer (mCRC)
Official title Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07171554
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Haemoglobin at least 10.0 g/dL.
You likely can't join 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lørenskog, Akershus, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lørenskog, Akershus, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.