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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 8, 2018
Last Update Posted : November 25, 2019
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 : December 2020
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine





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

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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

  • 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 for CRC in the metastatic setting, permitted in the neoadjuvant and adjuvant settings
  • Scheduled to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab
  • Availability of archival primary tumour tissue block (FFPE) obtained at the time of the initial diagnosis

Exclusion Criteria:

  • Patient with rectal cancer that has received any neo-adjuvant therapy before surgical resection of the primary tumour
  • 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.

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 Not yet recruiting
Dublin, Ireland
Contact: Patrick Morris, Dr         
St Vincent's University Hospital Not yet 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     History of Changes
Other Study ID Numbers: CTRIAL-IE 17-26
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: October 2019
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