Identification of New Patient Stratification Tools in MSS RAS mt mCRC

NCT03699111 | Completed

• 1 other identifier: CTRIAL-IE 17-26
• Study Type: observational
• Target: 29
• Locations: 3 countries
• Sites: 10

Brief 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

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

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

Study Population

All patients with stage IV MSS RAS mutant colorectal cancer

You may qualify if:

• 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
• 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
• 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).

You may not qualify if:

• Patient with CRC that has received any therapy for CRC before:
• surgical resection of tissue that would be utilised in this study
• 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.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (10)

Private Practice Oncology, Heidelberg

Heidelberg, Germany

Location

University Hospital, Mannheim

Mannheim, Germany

Location

Private Practice Oncology, Speyer

Speyer, Germany

Location

Bon Secours Hospital, Cork

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

St Vincent's University Hospital

Dublin, Ireland

Location

Tallaght University Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Institut Catala d'Oncologia

Barcelona, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: September 19, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 3, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (5); ES (2); DE (3)