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The EU-funded project CCE-DART (CCE Building Data Rich Clinical Trials) aims to establish cancer studies that are more flexible and easier to conduct than traditional studies. The treatment should also be able to be individually adapted during the course of the study. The participating experts from the seven European cancer centres of the Cancer Core Europe (CCE) consortium and four other partner organisations are relying on innovative technology and modern digital platforms. A total of five departments at the DKFZ and NCT Heidelberg are involved in the initiative.

So-called randomised controlled trials are considered the gold standard for testing the effectiveness of treatment approaches. Patients with the same disease are randomly assigned to either the study group or the control group. At the end, a comparison is made: What was the effect of the therapeutic intervention being tested compared to no treatment or a standard treatment? Although this procedure is very suitable for validating the effectiveness of therapeutic measures, it does not allow any adjustments during the course of the study. This is a particular disadvantage in the academic setting, as scientists are constantly adding new knowledge.

Furthermore, it is now clear that cancer therapy should ideally be precisely tailored to the individual, which is not possible in randomised controlled trials. Therefore, experts feel that the rigidity and limitations of traditional clinical trial designs need to be overcome. Instead, novel designs are needed that allow therapies to be adapted to different disease situations. This is the only way to ultimately identify the optimal treatment for the individual patient. 

The newly launched EU-funded CCE project Building Data Rich Clinical Trials (CCE-DART) now aims to promote and further develop precisely such innovative, new types of cancer studies. The project is led and coordinated by Elena Garralda, Director of the Molecular Cancer Therapy Research Unit at the Vall d'Hebron Institute of Oncology (VHIO) in Barcelona. Also on board are several experts from the seven leading European cancer centres of the CCE network*, of which the DKFZ is a member together with the NCT Heidelberg, as well as four other partners**. CCE-DART is funded by the European Union's Horizon 2020 research and innovation programme.

"The stated goal of the initiative is to drive the development of a new generation of more adaptable, efficient study designs in cancer research," explains Professor Klaus Maier-Hein, whose department "Medical Image Processing" coordinates the CCE-DART project at DKFZ. In addition, the aim is to work towards faster application of novel techniques and methods in the clinic, the image processing expert continues.

Novel IT tools are to lift the development and implementation of clinical studies completely into the digital age. According to Maier-Hein, this includes using both established and new data sources and systematically bundling and analysing the corresponding information. "In this way, we want to offer doctors a more solid basis for decision-making that also takes into account those scientific discoveries that are made during the study period," he explains. He says it is also important for them to involve the cancer patients themselves in the design and conduct of the trials. In the long run, this will all benefit the patients, Maier-Hein is convinced.

One of CCE-DART's first tasks is to develop a molecular database in which cancer mutations are collected in a standardised way. The foundations for such a digital platform were laid by the "Basket of Baskets" study, BoB for short, which started in 2018. "Basket" studies are a new type of clinical trial in which patients whose tumour cells have the same mutations are treated with the same drug - regardless of the type of cancer. Affected patients are divided into "baskets", so to speak, depending on the type of mutation. The therapies ultimately aim to block the genetic changes or their effects. Extensive documentation of the genetic changes in tumour cells, for example, allows researchers to carry out treatments in populations with the same mutations.

In their work, the project partners can draw on the shared infrastructure and wealth of experience of the CCE sites. The DKFZ and NCT Heidelberg alone contribute the expertise of five departments. In addition to "Medical Image Processing", Professor Stefan Fröhling's "Translational Medical Oncology" section is involved, which has excellent knowledge of molecular diagnostics and precision oncology. Professor Heinz-Peter Schlemmer and his "Radiology" section contribute extensive experience regarding imaging procedures for diagnostic, therapeutic and scientific purposes. The NCT Study Centre around Professor Richard Schlenk, in turn, has extensive experience in the planning and implementation of clinical studies. And the Department of "Health Economics" headed by Professor Michael Schlander is constantly expanding the current state of knowledge about the costs and cost-effectiveness of prevention, early detection, diagnosis and treatment of cancer. Together with the other project partners, the combined expertise of the CCE-DART project is a pioneer in Europe when it comes to the design, planning and implementation of clinical cancer studies. Therefore, Klaus Maier-Hein is convinced that more efficient, personalised and effective clinical trials in oncology can be conducted in the future thanks to the initiative.

Contact person:

For further information please contact Prof. Klaus Maier-Hein
E-mail: K.Maier-Hein@dkfz-heidelberg.de
Phone: +49 6221 423545

*Cancer Core Europe (CCE) Consortium Members:

• Vall d'Hebron Institute of Oncology, Barcelona, Spain.
• Karolinska Institute, Stockholm, Sweden.
• Cambridge Cancer Center, Cambridge, Great Britain.
• National Center for Tumour Diseases Heidelberg and German Cancer Research Center, Heidelberg, Germany.
• Netherlands Cancer Institute, Amsterdam, Netherlands.
• National Cancer Institute of Milan, Italy.
• Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.

**Other partners:

• Digital Experimental Cancer Medicine Team, Manchester, UK.
• The Hyve, Utrecht, Holland.
• DataRiver, Modena, Italy.
• Form Vision, Abcoude, Holland.

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