The COLOSSUS translational study

COLOSSUS – Advancing a Precision Medicine Paradigm in Metastatic Colorectal Cancer: Systems Based Patient Stratification Solutions to create cost-effective, predictive diagnostic tools

 

What is the aim of the COLOSSUS study?

Colorectal cancer is the third most common cancer in Europe. In many cases treatment shows good results; however, there are patients who do not benefit from treatment or develop resistance to therapy.

COLOSSUS seeks to identify new biomarkers and classifiers for microsatellite stable RAS mutated colorectal cancer. Our aim is to develop new diagnostics and therapeutic options for patients bearing this type of cancer after they develop resistance to the current standard of care, and for whom there are no further treatment options currently available.

Our ultimate goal is to improve treatment outcomes for patients and deliver targeted and personalised treatment solutions.

 

Who can participate?

There are a number of criteria that patients must meet in order to participate in the study.

The key criteria for participating are listed below:

  • Diagnosis of Stage IV microsatellite stable (MSS) RAS mutant colorectal cancer.
  • Scheduled to receive standard of care chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab
  • The ability to give signed informed consent prior to any study-specific procedures and willing and able to comply with the protocol.
  • Age 18 years or over.

 

What do participants have to do?

Participants will be asked to:

  1. Contribute blood samples at two, possibly three different time points during the study.
  2. Provide access to the tissue which was taken during surgical treatment for colorectal cancer.
  3. Fill in two short questionnaires at two different time points to collect information about their well-being.
  4. Provide access to their clinical information to collect specific data for this study.

 

Who is carrying out the study?

This international, multi-centre study is organised and sponsored by Cancer Trials Ireland on behalf of the Chief Investigators Prof Ray McDermott (Ireland), Prof Matthias Ebert (Germany) and Prof Josep Tabernero (Spain) and a collaborative group of clinicians and scientists based in Ireland, the UK, Germany, Belgium, and Spain. The study is funded by a grant from the European Union (EU) Horizon 2020 research and innovation program and is open at hospitals in Ireland, Spain and Germany.

 

Who has approved the study?

This study has been approved by local Research Ethics Committees.

 

Where can I find more information?

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 will find more information at cancertrials.ie and clinicaltrials.gov.

 

Where are the participating hospital located?

In Ireland the following hospitals are participating:

  • University Hospital Galway
  • Bon Secours Hospital Cork
  • Tallaght University Hospital, Dublin
  • Vincent’s University Hospital, Dublin
  • Beaumont Hospital, Dublin

In Germany there are:

  • University Hospital Mannheim
  • Onkologische Schwerpunktpraxis Speyer
  • Onkologische Schwerpunktpraxis Heidelberg

And the two Spanish hospitals are:

  • Hospital Universitari Vall d’Hebron, Barcelona
  • Institut Catala d’Oncologia; L’Hospitalet de Llobregat, Barcelona

 

Contact:  Cancer Trials Ireland, Innovation House, Glasnevin Dublin 11, Ireland

Tel: 353 (1) 6677211     Email: info@cancertrials.ie

COLOSSUS study team at Bon Secour Cork: Back row L-R: Dr.Raimundas Galiauskas, Dr Conleth Murphy Dr Brian Bird Front Row L-R: Aoife Crowe, Aoife O’Shea, Evelyn O Sullivan Greene, Siobhan Finn, Hadia Khan

COLOSSUS study team at Institut Catala d’Oncologia; L’Hospitalet de Llobregat, Barcelona: Left to right:  Isabel Padrol (Project nurse), Dr Ramon Salazar (Head of the Medical Oncology Unit, IP), Dr. Cristina Santos (Medical Oncologist and IP) and Dr Paula Fernández Calotti (Project manager).

COLOSSUS study team at University Hospital Mannheim

COLOSSUS study team at the Hospital Universitari Vall d’Hebron, Barcelona: L to R, Iosune Baraibar, medical oncologist; Mireia Sanchis, Project Manager; Ariadna Garcia, Research Nurse; Javier Ros, Medical Oncologist; Javier Gonzalo, Project Manager.