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

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ClinicalTrials.gov Identifier: NCT03699111
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

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

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Study Type : Observational
Estimated Enrollment : 163 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



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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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


Contacts
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Contact: Cancer Trials Ireland, Innovation House, Glasnevin Dublin 11, Ireland 353 (1) 6677211 info@cancertrials.ie

Locations
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Germany
Private Practice Oncology, Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Stefan Fuxius, Dr. Med.         
University Hospital, Mannheim Recruiting
Mannheim, Germany
Contact: Matthias Ebert, Prof         
Private Practice Oncology, Speyer Recruiting
Speyer, Germany
Contact: Lars Scheuer, Dr med.         
Ireland
Bon Secours Hospital, Cork Recruiting
Cork, Ireland
Contact: Brian Bird, Dr         
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Patrick Morris, Dr         
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Ray McDermott, Dr         
Tallaght University Hospital Recruiting
Dublin, Ireland
Contact: Ray McDermott, Dr         
University Hospital Galway Recruiting
Galway, Ireland
Contact: Greg Leonard, Dr         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Rodrigo Dienstmann, Dr         
Institut Catala d'Oncologia Recruiting
Barcelona, Spain
Contact: Ramon Salazar Soler, Dr         
Sponsors and Collaborators
Cancer Trials Ireland
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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 9, 2020
Last Verified: December 2020
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