Identification of New Patient Stratification Tools in MSS RAS mt mCRC (COLOSSUS)

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

Study Overview

• Status: Completed
• Conditions: Advanced 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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Private Practice Oncology, Heidelberg
  • Mannheim, Germany
    • University Hospital, Mannheim
  • Speyer, Germany
    • Private Practice Oncology, Speyer
• Ireland
  • Cork, Ireland
    • Bon Secours Hospital, Cork
  • Dublin, Ireland
    • Beaumont Hospital
  • Dublin, Ireland
    • St Vincent's University Hospital
  • Dublin, Ireland
    • Tallaght University Hospital
  • Galway, Ireland
    • University Hospital Galway
• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Institut Catala d'Oncologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with stage IV MSS RAS mutant colorectal cancer

Description

Inclusion criteria

Patient Status

1. Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
2. Age ≥ 18 years,
3. ECOG status of ≤ 2,

4. At least 16 weeks of life expectancy at time of entry into the study.

   Disease-related

5. Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
6. Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
7. No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
8. 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),

9. Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue from:

   1. Preferred: surgical resection of the primary or metastatic tumour

      or

   2. 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).

Exclusion Criteria

1. Patient with CRC that has received any therapy for CRC before:

   1. surgical resection of tissue that would be utilised in this study

      or

   2. biopsy procedure for tissue that would be utilised in this study,
2. Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
3. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
4. Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 3, 2022

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CTRIAL-IE 17-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No