CANCER-ID

Cancer treatment and monitoring through identification of circulating tumour cells and tumour related nucleic acids in blood
CANCER-ID logo

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 11
Grant agreement number
115749

Type of Action: 
RIA (Research and Innovation Action)

Contributions
IMI Funding
6 620 000
EFPIA in kind
7 565 692
Other
6 332 600
Total Cost
20 518 292

Summary

Doctors need samples of cancer cells to determine what treatment is most appropriate and to monitor how well a treatment is working. Obtaining these cells usually requires a biopsy, an often invasive procedure. The CANCER-ID project aims to develop new, less invasive ways of capturing cancer cells and genetic material from tumours from blood samples and analysing them for clues to what treatment is needed and how well drugs are working. The project will focus initially on specific types of lung and breast cancer.

Monitoring treatment response still challenging
With more than 3 million new cases and 1.7 million deaths each year, cancer represents the second most important cause of death and illness in Europe, after cardio-vascular disease. New, more targeted treatments are emerging and a significant proportion of cancers can be cured or at least their progression can be slowed, especially if they are detected early. However, one of the main problems for doctors and patients remains monitoring the response to treatment in real time and detecting potential tumour mutations which can lead to drug resistance.

Cancer clues hiding in the blood
Currently tissue biopsies are used to diagnose and monitor the disease, but doctors cannot perform these too often because they are invasive, costly, and often risky for the patient. However, cancer is a highly dynamic disease and real-time diagnostic evaluation is very much needed to determine the best personalised treatment for patients at a given time.

Now a new solution is on the horizon. Tumours shed cells and fragments of DNA into the bloodstream and these ‘biomarkers’ can potentially be used to non-invasively screen for early-stage cancers, monitor responses to treatment and help explain why some cancers are resistant to therapies. Technical advances over the last two decades have enabled the extraction of these biomarkers from the blood, in a process which is called ‘liquid biopsy’. Although promising, this new method is not without challenges: looking for these biomarkers in the blood is often like looking for a needle in the haystack made up of billions of normal blood cells. Furthermore, a comprehensive evaluation, validation and head-to-head comparison of these new technologies have not yet been done. IMI’s CANCER-ID project aims to fill this gap.

Collaborative effort needed
By bringing together companies and institutions in the fields of tumour biology and cancer therapy, biomarker development, clinical sciences and bioinformatics, as well as regulatory agencies and patient advocacy groups, CANCER-ID will compare, evaluate and validate the most promising non-invasive technologies for liquid biopsy. With its over 30 partners from across Europe / the world, this project will bridge the gap between research focused on these novel methods and validating the most mature technologies so they can be adopted and brought to the patients as soon as possible.

The project will be divided into three key phases:

  1. In the pre-evaluation phase, liquid biopsy technologies will be evaluated and the criteria will be set for any of the technologies to move to the next phase.
  2. In the technical evaluation phase, the technologies identified as promising will be tested on patient samples.
  3. In the third stage, validated methods will be used on patients as part of clinical studies.  

Lung and breast cancer as pilots
Validating these new technologies on all cancer types would be unmanageable. That’s why the project will focus on two-types of cancer: lung and breast cancer. Between them, lung and breast cancer account for approximately 760 000 new cases of cancer per year in the EU and are responsible for more than 50% of cancer-related deaths in women. Blood-based diagnostics will be important to improve treatment and to design new clinical trials in these patients.

More specifically, these two types of cancer have been selected for the following reasons:

  • Lung cancer is the most common cause of cancer-related deaths worldwide. In the EU, lung cancer is the leading cause of cancer death among men in all countries except Sweden and women die from lung cancer more commonly than from breast cancer in a growing number of countries. Treatments with targeted drugs perform better than traditional chemotherapy. However, one obstacle is the difficulty in obtaining serial biopsies to chart tumour evolution and the emergence of drug resistance. For these reasons, CANCER-ID has selected lung cancer for development, optimisation and standardisation of the liquid biopsy biomarkers.
  • Breast cancer is the most common malignancy in women. Although several therapeutic options are readily available, resistance to these therapies often significantly limits the success rate. HER2 is the most prominent molecular target in breast cancer and it defines a clear molecular subtype. In CANCER-ID, researchers will focus on breast cancer patients who failed to respond to HER2-targeted therapies. Resistance to HER2-targeted therapies represents a serious medical problem and there is an urgent need to develop novel diagnostic tests for the early detection of resistance.

Both patients and industry to benefit
Once validated and approved for use in patients, these new methods will have a significant value for patients, physicians and payers since they will prevent exposure of patients to drugs that are unlikely to be beneficial. Moreover, validated biomarker tests will be extremely important for the pharmaceutical industry as they will help reduce the very high dropout rate in clinical development by selecting the right patients for the right drugs.

Achievements & News

Developing liquid biopsy tests to diagnose cancer
June 2018

Liquid biopsies can help to diagnose cancer in its early stages, and assist clinicians in monitoring the impact of treatment at any point. While offering great potential, a lack of standardised assays – or tests – have hampered research and slowed clinical adoption. The CANCER-ID project brought together 38 partners from 13 European countries, as well as groups from the US and a company in Singapore, to develop and validate standardised operating procedures for liquid biopsies.###

'Liquid biopsies pose a very difficult analytical challenge because we are looking for very rare events,' says CANCER-ID academic coordinator Klaus Pantel of the University Medical Center Hamburg-Eppendorf. Tumour cells can be difficult to detect in the human bloodstream, with sometimes less than one tumour cell to every million white blood cells. The CANCER-ID team focused on four specific work streams covering all aspects of liquid biopsy testing for cancer. Specifically, these included developing the criteria for evaluating circulating tumour cells; defining the methods for analysis of nucleic acids; developing clinic-ready protocols for liquid biopsy testing; and creating protocols for the management and storage of data. Together, they provide a comprehensive framework for using liquid biopsies. Informed by both public and private partners, the protocols are designed to provide best-practice guidelines and will be made freely available via open-source platforms, providing a standardised basis for research and, in the future, clinical practice.

CANCER-ID method marks step towards liquid biopsies for cancer patients
April 2018

Scientists from the CANCER-ID project have developed a streamlined procedure for studying certain alterations in cancer cells found circulating in the blood stream. The method could prove useful in helping clinicians to better identify which treatments will work in which patients, and to monitor disease progression. ###Cancerous tumours regularly shed individual cells into the blood stream. If captured through a blood test, these ‘circulating tumour cells’ (CTCs) have the potential to provide a lot of information about the state of the tumour. This is particularly important for cancers that cannot be biopsied without major surgery, for example. This study focused on the analysis of copy number alterations (CNAs) in the tumour cells; CNAs are mutations where multiple copies of a gene are found in the genome. Different CNA profiles have been linked to increased response or resistance to different types of drugs. However, current techniques to analyse CNAs are complex and not easy to apply in the clinic. In PLoS ONE, the CANCER-ID team describes a robust yet simple, one-step method to detect the number of CNAs in single cells. According to lead author Nicolò Manaresi of Menarini Silicon Biosystems, the new technique, dubbed Ampli1, provides comparable or superior performance at lower cost than current methods. ‘Our streamlined workflow will further decrease the cost of copy number analysis in the future and pave the way to a simpler blood test to study cancer heterogeneity in liquid biopsy,’ he said.

Read the Menarini Silicon Biosystems press release

CANCER-ID finds clues to cancer drug effectiveness in blood
May 2017

Changes in the genes of cancer cells found in the blood could help to identify patients for whom a standard drug is most likely to be effective, according to a new study by scientists from IMI’s CANCER-ID project. The findings, published in the journal Cancer Research, could ultimately result in tests that would allow doctors to distinguish between patients who should keep taking the drug and patients who would benefit from trying alternative treatments.### The scientists focused on a form of non-small cell lung cancer (NSCLC) that is driven by mutations in a gene called ALK. There is a drug, crizotinib, that targets ALK. However, while crizotinib helps some patients to keep the cancer in check for years, in others its effects last for just a few months. The challenge for doctors is to identify which patients are unlikely to respond well to treatment, so that they can be offered a different treatment. It is not practical to subject NSCLC patients to regular biopsies to track the progress of their disease. However, some cancer cells break off from the tumour and enter the blood stream. These circulating tumour cells (CTCs) can be identified and analysed via a simple blood test. In this latest study, scientists took blood samples from ALK-NSCLC patients both before and two months after starting crizotinib treatment. They then analysed the CTCs found in the blood samples for both ALK rearrangements and multiple copies of the ALK gene. This revealed that patients who showed a decrease in the number of CTCs with multiple copies of the ALK gene after two months on crizotinib had an average progression free survival (i.e. their condition did not worsen) of 14 months. In comparison, patients where the number of CTCs with multiple copies of the ALK gene stayed the same or increased had an average progression free survival of just six months. ‘In this study, we showed that analysis of ALK copy number in CTCs before starting crizotinib treatment and after two months of crizotinib treatment may provide a biomarker for predicting the effectiveness of the therapeutic,’ said the lead author of the paper, Françoise Farace of INSERM in France. ‘This is important because there is currently no means of distinguishing those patients likely to gain long-term benefit from crizotinib from those who are not and who should consider trying some of the newer ALK-targeted therapeutics that have been more recently developed.’ Larger studies are now needed to validate the findings, and the technology used to study the CTCs is not yet ready for large-scale application. Nevertheless, Dr Farace points out: "The results reflect the potential of liquid biopsies to monitor treatment response in real time and tailor treatments at the individual patient level."

Could a blood test offer clues to cancer gene activity?
September 2016

Scientists from IMI’s CANCER-ID project have obtained unprecedented levels of information on genetic activity in cancerous tumours by analysing fragments of tumour DNA taken from blood samples. The study, published in Nature Genetics, adds to our understanding of the genetics of cancer and will aid in the development of new treatments.### Ultimately, it should help to improve cancer diagnosis and treatment. Cancerous tumours regularly shed fragments of genetic material like DNA into the blood, and there is a lot of research into the best ways of capturing and analysing this material. Until now, the most advanced techniques allowed researchers to identify which mutations were present in the tumour DNA. Now, CANCER-ID researchers from the Medical University of Graz have succeeded in going a step further and identifying whether the genes are actually active or not. According to the researchers, knowing which genes are active in tumours will aid in the identification of potential drug targets and could also improve the clinical management of patients with cancer. Looking to the future, the team hopes to use their new technique to determine whether gene activity remains stable in tumours or whether it varies in response to external factors such as treatments.

IMI welcomes a new project: CANCER-ID
CANCER-ID, a new IMI project to validate blood-based biomarkers for cancer, has just got started. Blood-based biomarkers such as circulating tumour cells, circulating free tumour DNA (cfDNA) and microRNAs (miRNAs) are potential indicators for the tumour burden of patients living with cancer. Derivation of these markers from blood may offer an invaluable tool for cancer therapy: ###blood-based tests are instrumental when biopsies of the tumour are not accessible, and they may allow a close follow-up of disease markers offering a means to monitor the efficacy of treatment and potentially improve the choice of treatment options. CANCER-ID brings together 33 partners from 13 countries -  experts from academic and clinical research, innovative SMEs, diagnostics companies and the pharmaceutical industry - aiming at the establishment of standard protocols for and clinical validation of blood-based biomarkers. The total budget of CANCER-ID is EUR 14.5 million. Find out more on the project website
(April 2015)

Participants Show participants on map

EFPIA companies
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Eli Lilly and Company Limited, Basingstoke, United Kingdom
  • Institut De Recherches Servier, Suresnes, France
  • Orion Oyj, Espoo, Finland
  • Silicon Biosystems S.p.A., Bologna, Italy
Universities, research organisations, public bodies, non-profit groups
  • ANGLE Europe Ltd, Guildford, United Kingdom
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Agilent Technologies Sales & Services GmbH & Co. KG, Waldbronn, Germany
  • Charite - Universitaetsmedizin Berlin, Berlin, Germany
  • Clearbridge Biomedics Pte Ltd, Singapore, Singapore
  • Deutsches Krebsforschungszentrum Heidelberg, Heidelberg, Germany
  • Ethniko Kai Kapodistriako Panepistimio Athinon, Athens, Greece
  • European Organisation For Research And Treatment Of Cancer Aisbl, Brussels, Belgium
  • Heinrich-Heine-Universitaet Duesseldorf, Düsseldorf, Germany
  • Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä, Helsinki, Finland
  • Institut Curie, Paris, France
  • Institut Gustave Roussy, Villejuif, France
  • Istituto Oncologico Veneto, Padova, Italy
  • Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften Ev, Munich, Germany
  • Medizinische Universitat Graz, Graz, Austria
  • Oslo Universitetssykehus Hf, Oslo, Norway
  • Qiagen GMBH, Hilden, Germany
  • Siemens Healthcare Diagnostics Products GMBH, Marburg, Germany
  • Terumo BCT Inc., Lakewood, United States
  • The University Of Manchester, Manchester, United Kingdom
  • Universita Degli Studi Di Torino, Turin, Italy
  • Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany
  • Universite De Montpellier, Montpellier, France
  • Universiteit Twente, Enschede, Netherlands
  • University of Cambridge, Cambridge, United Kingdom
Small and medium-sized enterprises (SMEs)
  • Agena Bioscience GmbH, Hamburg, Germany
  • Alacris Theranostics GMBH, Berlin, Germany
  • Arttic, Paris, France
  • Gilupi GMBH, Potsdam, Germany
  • Tataa Biocenter AB, Göteborg, Sweden
  • VyCAP BV, Deventer, Netherlands
Non EFPIA companies
  • Luxembourg Institute Of Health, Luxembourg, Luxembourg

CONTACT

Project coordinator
Thomas Schlange
Bayer Aktiengesellschaft
Germany
+49 202 36 5403
thomas.schlange[at]bayer.com
Managing entity
Klaus Pantel
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
+49 (0)40 7410-53503
pantel[at]uke.de