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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699111
Recruitment Status : Active, not recruiting
First Posted : October 9, 2018
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Study Description
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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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood and tissue.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with stage IV MSS RAS mutant colorectal cancer
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699111


Locations
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Germany
Private Practice Oncology, Heidelberg
Heidelberg, Germany
University Hospital, Mannheim
Mannheim, Germany
Private Practice Oncology, Speyer
Speyer, Germany
Ireland
Bon Secours Hospital, Cork
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Institut Catala d'Oncologia
Barcelona, Spain
Sponsors and Collaborators
Cancer Trials Ireland
More Information
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT03699111    
Other Study ID Numbers: CTRIAL-IE 17-26
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases