What is SPECTAcolor? SPECTAcolor stands for ‘Screening Patients for Efficient Clinical Trial Access in advanced colorectal cancer’.

SPECTAcolor is the first ever prospective fully annotated tumour samples Biobank and Biomarker analysis platform for genetic profiling of patients suffering from advanced colorectal cancer.

This platform unique in its kind joins up clinical forces at a Pan-European level to develop personalized treatments based on the results of the tissue sampling analysis. Supported by a network of  32 clinical centres in 11 countries, this initiative has the ultimate goal of enabling better access to treatment options. An estimated number of 600 >1000 patients with advanced colorectal cancer (CRC) are expected to enrol on a yearly basis. To date, the EORTC is proud to announce that 919 patients have enrolled since the official start of the biobank on 20 September 2013!

Funded by a corporate social responsibility initiative of Walgreens Boots Alliance, SPECTAcolor is an initiative within the framework of the research programme of the EORTC. Created in 1962 by European cancer specialists, the EORTC is an international non-profit research organization governed by Belgian law whose mission is to improve survival and quality of life of patients with cancer.

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839 patients enrolled since the opening of the biobank in September 2013!

Breakdown of patients accrued per country as of 11 December 2015
Belgium 136
Cyprus 22
France 16
Germany 339
Greece 8
Italy 39
Poland 1
Portugal 10
Spain 230
Sweden 9
Switzerland 109
Total number of patients accrued 919

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An innovative path to new colorectal cancer treatments

EORTC has connected 32 leading clinical centers across Europe to set-up the first pan-European Biomarker Screening Platform dedicated to patients with advanced colorectal cancer (CRC).

By screening patients for biomarkers relevant to targeted clinical trials, SPECTAcolor increases the opportunities for colorectal cancer patients to access clinical trials with new molecularly defined approaches and simultaneously decreases the cost and logistical pressure of setting up new trials.

SPECTAcolor

 Project Summary

SPECTAcolor is promoting personalized cancer treatment by facilitating the enrollment of patients with advanced colorectal cancer into targeted clinical trials. This process is done through the analysis and characterization of the patient’s tumor at molecular level. Depending on the screening results, participation in downstream clinical trials with molecular defined inclusion criteria may be offered to the patient.

To do so, EORTC has connected over 30 leading clinical centers across Europe to set-up the first pan-European Biomarker Screening Platform dedicated to patients with advanced colorectal cancer (CRC). This Pan-European initiative avoids duplication of efforts which therefore simultaneously decreases the cost and logistics usually generated when setting up new trials.

In short SPECTAcolor is:

  • A Pan-European infrastructure composed of top level recruiting clinical centers; a biobank and certified laboratories for diagnostic essays that are conducted by the EORTC Headquarters
  • That proceeds to exhaustive molecular characterization of Advanced Stage Colorectal Cancer patients
  • In view to set up translational research-based clinical trials

Result of a fruitful partnership between the EORTC and the Alliance Boots Group, SPECTAcolor is 100% funded by Alliance Boots through its Corporate Social Responsibility programme.

“SPECTAcolor is a unique model of partnership as it connects all stakeholders involved in drug development, enhancing joint expertise to benefit the patients as well as tax payers ” explains Denis Lacombe, EORTC Headquarter Director.

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Prof. Sabine Tejpar in Leuven, Belgium co-Coordinator of this project adds, “SPECTAcolor will facilitate the transformation of experimental discoveries into new treatments, have a significant clinical impact, and provide feedback from the clinic to the bench. It should be seen as a constantly evolving system with the ability to support new trials with innovative treatments.”

How does the biobank work?

How does SPECTAcolor works?

Initially at the basis of the whole biobank initiative, the EORTC Headquarters supervise and endorse the entirety of the biobank activities.

The SPECTAcolor biobank is a dynamic consortium between the following acting partners:

  • The EORTC Headquarters are the clinical infrastructure that provides methodological, operational and legal support to the SPECTAcolor biobank.
  • The Institute of Pathology of the Medical Institute of the Dresden Biobank that receives and processes all collected tumour paraffin embedded tissue samples sent from the clinical centers. To date, the biobank entails a European network of over 30 clinical centers from 11 countries that collaborate together on the tissue sampling collection.
  • The Diagnostics laboratories are the laboratories in charge of the biomarker analysis. Biomarkers analysis have to comply with the EORTC guidelines for the quality assurance of biomarkers in clinical trials. There are currently three laboratories empowered to perform these tests: The Institute of Pathology of the Medical Institute of Dresden, Germany, the European Hospital George Pompidou in Paris, France and the University Hospital Gasthuisberg in Leuven, Belgium.

“SPECTAcolor is currently valued among its stakeholders as a varied and adaptable consortium that meets the needs and evolution of the science” Denis Lacombe, EORTC Headquarters Director

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Governance

The SPECTAcolor biobank is governed by ‘The network of institutions Consortium Agreement’ whose governance and management works as follows:

The Biobank is governed by an Executive Committee that meets once a month to discuss project issues and a Steering Committee that meets bi-annually to ensure a smooth project management.

The Steering Committee monitors both the Biobank performance and progress whilst ensuring cohesion and interaction among partners. The Steering Committee has an important role to play in discoveries in prognostic and predictive markers. The Steering Committee is composed of:  three Study coordinators, a storage facility representative, the Chair and a representative of the EORTC Gastro Intestinal group, an EORTC Director and Contract Research Organization, a representative from each recruiting center, the representative of the EORTC Pathobiology Group and Quality Assurance, a translational Research Coordinator, a representative of the European Society of Pathology, a Patient advocacy representative as well as an external expert.

The Executive Committee carries out the decision of the Steering Committee and manages the day to day work of the project. The Executive Committee meets once a month. The Executive Committee is composed of: the study coordinators, a storage facility representative, the chair of the EORTC Gastro Intestinal group, the representative of the EORTC Pathobiology Group and Quality Assurance, EORTC clinical research physicians, a project manager, a data manager and a statistician.

Biobank workflow

The EORTC plays a crucial role in the management of the Biobank operational framework. The EORTC facilitates the exchange of tissue samples across Europe as well as the centralization of data respectively provided by the clinical centers, the Biobank and the diagnostic laboratories.

How does it work?

workflow

The clinical centers recruit the patients (figure 2). The tissue sample is sent preferably  in the form of paraffin block (1) to the Dresden biobank to extract the DNA and RNA, meanwhile both the clinical and pathological data of this sample are sent to the EORTC centralized VISTA database where all data is gathered and stored (2). The sample shipment is tracked by EORTC by means of a web-based tool that keeps track records of samples sent throughout Europe.

Upon receipt of the tissue samples, the biobank updates the web-based tool with pathology, RNA and DNA extractions analysis results (3). The DNA sample extraction is then shipped to the diagnostic laboratories to perform the biomarker analysis (4, 5). Ultimately, the Sanger Institute who is partnering with us on the biobank will provide at a later stage, next generation sequencing information about the biomarker analysis, refining thus even more the tissue sample analysis.

Any unused remaining biological material will be stored at the biobank or alternatively sent back to the clinical center if requested.

Upon completion of the biomarker analysis, results are uploaded to the EORTC centralized database and the physician of the patient is notified whether the patient is eligible to enter a clinical trial matching his biomarker criteria (7). All patient clinical data status is updated every 6 months.

A comprehensive account of all steps taken is recorded in the EORTC centralized database to ensure a thorough follow-up at all times.

Scientific team

The EORTC Scientific team comprehends  members of: the Steering Committee,  the Executive Committee and the EORTC Headquarters.

Study coordinators

daniela-austDr. Daniela Aust, University of Dresden, Germany

Daniela Aust is attending pathologist at the Institute for Pathology of the TU Dresden, responsible for predictive pathology and gastrointestinal pathology including expert opinions on gastrointestinal dysplasia. She serves in interdisciplinary gastrointestinal tumor centers. Dr. Aust is involved in issuing the evidence-based guidelines for gastric cancer, ulcerative colitis and celiac disease. Her translational research focuses on colorectal carcinogenesis and phenotype-genotype correlations. She is a steering committee member of the EORTC GI Group as well as a member of other national and international professional organizations. Dr. Aust has authored more than 80 educational papers and scientific publications in peer-reviewed journals in addition to serving as a reviewer and on editorial boards.

gunnard-floprechtDr. Gunnar Folprecht, University of Dresden, Germany

Gunnar Folprecht works is medical oncologist at the University Cancer Center in Dresden, where he is responsible for the Daycare / outpatient Unit for Medical Oncology. He studied Medicine in Würzburg and Dresden (Germany). His scientific focus is medical and multidisciplinary treatment of colorectal cancer. He is the chair of the colorectal cancer task force of the EORTC Gastrointestinal Group and he is coordinating several clinical trials, mostly in colorectal cancer. He is the formal coordinating oncologist for the EORTC screening project that is supported by Alliance Boots.

sabine-tejparProfessor Sabine Tejpar, University Hospital Gasthuisberg Leuven, Belgium

Sabine Tejpar is Adjunct Clinical Head of the Department of Gastroenterology, Digestive Oncology Unit at the University Hospital Gasthuisberg in Leuven, Belgium. Professor Tejpar works part time as a clinician and researcher (Senior Clinical Investigator of the Fund for Scientific Research, Flanders Belgium), with a focus on basic and translational research in colorectal cancer. Her main research projects involve prognostic markers in adjuvant colorectal cancer and predictive markers for efficacy of EGFR inhibition. Professor Tejpar has published over 50 peer-reviewed publications and is an active member of the Gastrointestinal Group of the EORTC. She is a member of advisory board of several pharmaceutical companies in relation to new drug development and translational research in gastrointestinal cancer.

arnaud-rothArnaud Roth, MD CC, Oncosurgery Department of Medicine,  Geneva University Hospital, Switzerland

 Dr. Arnaud Roth received his medical degree from the Faculty of Medicine, University of Geneva, Switzerland. He trained in internal medicine at the University hospital of Geneva and at the Hammersmith Hospital in London (UK). Dr Roth also trained as a fellow in hemato-oncology for three years at the Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA. Dr. Roth is presently Consultant and senior lecturer in charge of the unit of Oncosurgery in the Department of Medicine, at Geneva University Hospital. Since 1981 he has been a member of Swiss Medical Society. Dr. Roth also serves as Chairman of the Gastro-Intestinal project group of the European Organization for Research and Treatment of Cancer (EORTC) since 2010. Dr. Roth has published over 90 peer-reviewed articles and several chapters in books on metastatic gastric and esophageal cancer, as well as on management of ano-rectal and colonic cancer. His present clinical and research interests are presently centered on gastro-intestinal tumors with research programs on prognostic biomarkers in colon cancer, new treatment strategy for the management of liver metastasis from colorectal cancers, and development of new systemic therapy in gastric cancer.

denis-lacombeDr. Denis Lacombe, MD, EORTC Headquarters Brussels, Belgium

Denis Lacombe graduated with his MD from the University of Marseilles (France) in 1988 and obtained a Master Post Doctoral Fellowship at The Roswell Park Cancer Institute (Buffalo, NY USA) for research in pharmacology and pharmacokinetics from 1989 to 1991. From 1991 to 1993, he worked as a Clinical Research Advisor in charge of the development of a new drug in oncology in the pharmaceutical industry.

Dr. Lacombe joined the EORTC in 1993 as a research fellow and quickly became a very active and productive Clinical Research Physician involved in the conduct of clinical research from protocol development through publication for a number of oncology indications from phase I to phase III. Dr. Lacombe contributed to the strategic evolution of the EORTC pan-European clinical and translational research infrastructure by setting up various supportive assets such as regulatory and pharmacovigilance expertise as well as partnership models with the pharmaceutical industry. Dr. Lacombe rose to the position of Director EORTC Headquarters in 2010, and in April 2015 was appointed EORTC Director General. In his current position, Denis Lacombe is now involved in the coordination and administration of all EORTC activities in order to promote the EORTC as a major European organization in Cancer Clinical and Translational Research and is responsible for the organization of scientific activities, public relations and medium term strategies as defined by the EORTC Board as well as for internal and external communications.

Dr. Lacombe is the author of well over 100 peer reviewed publications and communications that have had a positive impact on the future of cancer therapy.

vassilis-golfinopoulos

Dr.  Vassilis Golfinopoulos, MD, PhD, EORTC Headquarters Brussels, Belgium

Dr. Vassilis Golfinopoulos joined EORTC Headquarters as Medical Vice Director in September 2012, where he oversees the Medical and Pharmacovigilance, Translational Research, Radiotherapy and Imaging, and Quality of Life Departments. His tasks include development and implementation of the EORTC’s scientific strategy and support of initiatives put forth by the EORTC Board. Vassilis plays an instrumental role in both the organization’s SPECTA (screening patients for efficient clinical trial access) program and Cancer Survivorship initiative. He keeps his feet well-grounded in the EORTC’s daily clinical and translational research efforts through his role as clinical research physician for the EORTC Brain Tumor Group.Before joining the EORTC, Dr. Golfinopoulos was responsible for the sarcoma, melanoma, germ-cell, and part of the lung cancer inpatient and outpatient clinics at the Bank of Cyprus Oncology Center. Prior to that, he gained clinical experience in the inpatient and outpatient setting with all solid tumor types and research experience in multicenter phase I, II, and III clinical studies at the Ioannina University Hospital.

Vassilis earned his medical degree from the University of Patra Medical School, his Ph.D. from the University of Ioannina, and completed residencies in internal medicine and hematological oncology at the Theagenion Cancer Institute and in medical oncology at the University Hospital of Ioannina. As a research fellow at the Jules-Bordet Institute, he participated in a variety of projects conducted by the Functional Genomics and Translational Research Unit and the Department of Medical Oncology.

Development team

roger-stuppRoger Stupp, M.D President, EORTC

Roger Stupp, M.D., lead of the multidisciplinary brain tumor clinic at the Department of Neurosurgery of University of Lausanne Medical Center (CHUV), Switzerland was recently appointed Director of the Zurich Cancer Center and designated Director of the Department of Medical Oncology at the Zurich University Hospital, Switzerland. The dedicated clinical interests of Dr. Stupp include the multimodal management of brain tumors, head and neck and lung cancers, new drug development and the association of chemotherapy and radiation therapy. Dr. Stupp serves as President of EORTC and past Secretary of the EORTC Brain Tumor Group. Dr. Stupp is an editor for the European Journal of Cancer and is a member of several editorial boards including Journal of Clinical Oncology, and Neuro-Oncology.

francoise-meunierFrancoise Meunier, M.D, PhD, EORTC Headquarters Brussels, Belgium

Françoise Meunier served as EORTC Director General from 1991 through 2015 and oversaw the growth of the EORTC into an international world class cancer clinical research infrastructure. She has been been especially successful in developing the future generations of clinical oncologists, and the EORTC Fellowship Program is a testimony to this. Upon stepping down as Director General in 2015, Françoise remains active as EORTC Director Special Projects where she is a driving force behind activities such as EORTC cancer survivorship initiatives. She also lends her valuable experience to fundraising projects and sits on the board of the EORTC Cancer Research Fund.

She received her medical degree and her PhD from the Université Libre de Bruxelles and completed her research fellowship at the Memorial Sloan-Kettering Cancer Center in New York. She is also certified as a Pharmaceutical Medicine specialist by the Faculty of Pharmaceutical Medicine in the United Kingdom as well as in Belgium. Before joining the EORTC in 1991, Françoise Meunier was Head of the Infectious Diseases Department at the Institut Jules Bordet in Brussels. She has over 150 peer-reviewed published articles and is a member of numerous international oncology scientific societies. Professor Meunier is a member of the Belgian Royal Academy of Medicine and she was conferred the honorary title of Baroness by His Royal Majesty King Albert II of Belgium in 2007.

denis-lacombeDr. Denis Lacombe, EORTC Headquarters Brussels, Belgium

Denis Lacombe graduated with his MD from the University of Marseilles (France) in 1988 and obtained a Master Post Doctoral Fellowship at The Roswell Park Cancer Institute (Buffalo, NY USA) for research in pharmacology and pharmacokinetics from 1989 to 1991. From 1991 to 1993, he worked as a Clinical Research Advisor in charge of the development of a new drug in oncology in the pharmaceutical industry.

Dr. Lacombe joined the EORTC in 1993 as a research fellow and quickly became a very active and productive Clinical Research Physician involved in the conduct of clinical research from protocol development through publication for a number of oncology indications from phase I to phase III. Dr. Lacombe contributed to the strategic evolution of the EORTC pan-European clinical and translational research infrastructure by setting up various supportive assets such as regulatory and pharmacovigilance expertise as well as partnership models with the pharmaceutical industry. Dr. Lacombe rose to the position of Director EORTC Headquarters in 2010, and in April 2015 was appointed EORTC Director General. In his current position, Denis Lacombe is now involved in the coordination and administration of all EORTC activities in order to promote the EORTC as a major European organization in Cancer Clinical and Translational Research and is responsible for the organization of scientific activities, public relations and medium term strategies as defined by the EORTC Board as well as for internal and external communications.

Dr. Lacombe is the author of well over 100 peer reviewed publications and communications that have had a positive impact on the future of cancer therapy.

vassilis-golfinopoulosDr.  Vassilis Golfinopoulos, MD, PhD, EORTC Headquarters Brussels, Belgium

Dr. Vassilis Golfinopoulos joined EORTC Headquarters as Medical Vice Director in September 2012, where he oversees the Medical and Pharmacovigilance, Translational Research, Radiotherapy and Imaging, and Quality of Life Departments. His tasks include development and implementation of the EORTC’s scientific strategy and support of initiatives put forth by the EORTC Board. Vassilis plays an instrumental role in both the organization’s SPECTA (screening patients for efficient clinical trial access) program and Cancer Survivorship initiative. He keeps his feet well-grounded in the EORTC’s daily clinical and translational research efforts through his role as clinical research physician for the EORTC Brain Tumor Group.Before joining the EORTC, Dr. Golfinopoulos was responsible for the sarcoma, melanoma, germ-cell, and part of the lung cancer inpatient and outpatient clinics at the Bank of Cyprus Oncology Center. Prior to that, he gained clinical experience in the inpatient and outpatient setting with all solid tumor types and research experience in multicenter phase I, II, and III clinical studies at the Ioannina University Hospital.

Vassilis earned his medical degree from the University of Patra Medical School, his Ph.D. from the University of Ioannina, and completed residencies in internal medicine and hematological oncology at the Theagenion Cancer Institute and in medical oncology at the University Hospital of Ioannina. As a research fellow at the Jules-Bordet Institute, he participated in a variety of projects conducted by the Functional Genomics and Translational Research Unit and the Department of Medical Oncology.

christopher-mallabyHonorary Vice President, EORTC Cancer Research Fund, UK

Sir Christopher Mallaby, born in 1936, is the Honorary Vice President of the Cancer Research Fund which supports the work of EORTC. He held the chairmanship of the EORTC Charitable Trust  (now Cancer Research Fund) from 2001 until spring 2014. He is an Honorary Member of the Board of EORTC and Chairman of the Friends of EORTC, the UK Charity. He was British Ambassador to Germany from 1988 to 1992 and to France from 1992 to 1996. Sir Christopher Mallaby worked for ten years as a Managing Director in UBS Investment Bank. He has been a member of the boards of various companies in the UK, France and Germany. He has held senior voluntary positions in the same countries, including work in museums and universities.

victoria-agnewMrs. Victoria Agnew, EORTC Cancer research Fund and Friends of EORTC,UK

Victoria Agnew is the Director of the EORTC Cancer Research Fund. She is responsible for the management and administration of the Charity and of Friends of EORTC, the UK Charity. Mrs. Agnew is an honorary member of the Board of the EORTC as well as a Member of the Council of the EORTC Cancer Research Fund. She is also a Trustee of the Friends of EORTC. Before joining the EORTC Charitable Trust in 1998 (now EORTC Cancer Research Fund), Mrs. Agnew worked in the international oil and British commercial property sectors for many years before joining the National Gallery under the leadership of the Chairman, Lord Rothschild and Director, Neil McGregor in London to create support for the Gallery from the corporate sector for the first time. She left the National Gallery in 1993, to establish the World Monuments Fund in Britain with the famous historian, John Julius, Viscount, Norwich and Colin Amery, the eminent architectural historian.