Advanced Colorectal CancerCOLOSSUSNCT03699111
Identification of New Patient Stratification Tools in MSS RAS mt mCRC
An observational study of Advanced Colorectal Cancer, run by Cancer Trials Ireland at 10 sites in 3 countries.
Trial summary
This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- How many people
- 29 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 19 Sep 2018to 3 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients with stage IV MSS RAS mutant colorectal cancer
Who may be able to join
- Patient Status
- Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
- Age ≥ 18 years,
- ECOG status of ≤ 2,
- At least 16 weeks of life expectancy at time of entry into the study.
- Disease-related
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- Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
- Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
- No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
- Scheduled to receive or receiving SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation),
- Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue from:
- Preferred: surgical resection of the primary or metastatic tumour
- or
- Biopsy samples (biopsy taken at endoscope, needle core or surgical incision or excision) obtained from the primary or metastatic tumour.
- The archival FFPE tissue blocks must be obtained during initial diagnosis (before patient was exposed to any chemotherapy and/or radiation therapy).
Who cannot join
- Patient with CRC that has received any therapy for CRC before:
- surgical resection of tissue that would be utilised in this study
- or
- biopsy procedure for tissue that would be utilised in this study,
- Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
- Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
- Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Ireland5 sites
Bon Secours Hospital, Cork
Cork
Beaumont Hospital
Dublin
St Vincent's University Hospital
Dublin
Tallaght University Hospital
Dublin
University Hospital Galway
Galway
Germany3 sites
Private Practice Oncology, Heidelberg
Heidelberg
University Hospital, Mannheim
Mannheim
Private Practice Oncology, Speyer
Speyer
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona
Institut Catala d'Oncologia
Barcelona
About this study
Official title: Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS
This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer
Read the detailed description
The rational of COLOSSUS is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to MSS RAS mt mCRC patients
- Conditions
- Advanced Colorectal Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Stratification Tools
Identification and technical (analytical) validation of new patient stratification tools (COLOSSUS subtypes) in MSS RAS mt mCRC using a novel integrative systems biomedicine multi-omics discovery framework.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start19 Sep 2018
- Primary completion1 Apr 2022
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699111
- Sponsor's protocol ID
- CTRIAL-IE 17-26
- Acronym
- COLOSSUS
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS
- ClinicalTrials.gov ID
- NCT03699111
- Acronym / sponsor ID
- COLOSSUS / CTRIAL-IE 17-26
- Conditions
- Advanced Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer
Detailed description
The rational of COLOSSUS is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to MSS RAS mt mCRC patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with stage IV MSS RAS mutant colorectal cancer
Key inclusion criteria (15 listed)
- Patient Status
- Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
- Age ≥ 18 years,
- ECOG status of ≤ 2,
- At least 16 weeks of life expectancy at time of entry into the study.
Key exclusion criteria (7 listed)
- Patient with CRC that has received any therapy for CRC before:
- or
- Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
- Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
- Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stratification Tools
Time frame: 4 years
Identification and technical (analytical) validation of new patient stratification tools (COLOSSUS subtypes) in MSS RAS mt mCRC using a novel integrative systems biomedicine multi-omics discovery framework.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Cancer, run by Cancer Trials Ireland at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stratification Tools (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.