Received grant in 2025

DCCC has funded 65,000 DKK to the project.

Since 2022, Denmark has offered comprehensive genomic profiling to patients with incurable cancer in order to select targeted therapy. However, the evidence on clinical use of new targeted drugs remains sparse. Some are not yet commercially available through Named Patient Programs, while others have been rejected or not yet evaluated by the Danish Medicines Council. Additionally, data is not systematically collected, and access to these drugs varies across the country.

To address these challenges, a Phase IV prospective, non-randomised clinical trial is being initiated to investigate effect, safety and financial implications of commercially available, genomically targeted drugs to patients with incurable cancer.

As part of the study preparation, a protocol will be developed, a RedCap database established, and funding applications planned. To facilitate this process, the research team will organise a workshop for key stakeholders. This project aims to strengthen collaboration between clinicians, researchers, and regulatory authorities, ensuring a well-coordinated approach and increasing the likelihood of successful study implementation.

The project stakeholders expects the study to generate significant professional benefits, particularly by ensuring a national and standardised approach to the use of new genomically targeted cancer therapies for patients with incurable cancer. Additionally, the study aims to support the systematic collection of real-world data (RWD) on these therapies- both EMA-approved drugs and those available through Named Patient Programmes (NPPs) - to inform future decisions on adoption or potential rejection in Denmark.

The study will also evaluate the economic aspects of these treatments and aims to initiate translational research to identify novel predictive and resistance markers, which could help refine patient selection for these therapies. Ultimately, the project seeks to establish a national infrastructure to support the implementation of newly approved therapies granted conditional approval by the Danish Medicines Council.

Multidisciplinary organization

The project is anchored in DMCG Committee for Genomic Profiling, Danish National Molecular Tumor Board (DNMTB), DCCC Danish Research Centre for circulating tumor DNA guided treatment, and oncology departments across Denmark.

Project stakeholders 

Chief medical officers of the oncology departments:

  • Anders Krog Vistisen, Chief Medical Officer, Department of Oncology, Aalborg University Hospital
  • Anni Ravnsbæk Jensen, Chief Medical Officer, Kræftafdelingen, Aarhus University Hospital
  • Hanne Linnet, Chief Medical Officer, Department of Oncology, Regionhospital Gødstrup
  • Lars Henrik Jensen, Chief Medical Officer, Department of Oncology, Lillebaelt Hospital
  • Stefan Jeppesen, Chief Medical Officer, Department of Oncology, Odense University Hospital
  • Mads Nordahl Svendsen, Chief Medical Officer, Department of Oncology, Zealand University Hospital
  • Lisa Sengeløv, Chief Medical Officer, Department of Oncology, Herlev Hospital
  • Ulrik Lassen, Professor, Chief Medical Officer, Department of Oncology, Rigshospitalet

DMCG Committee for Genomic Profiling:

  • Camilla Qvortrup, Consultant, Department of Oncology, Rigshospitalet

Danish National Molecular Tumor Board:

  • Martin Højgaard, Specialty Registrar, Phase 1 Unit, Rigshospitalet
  • Britt Elmedal Laursen, Consultant, Associate Professor, MOMA & Department of Oncology, Aarhus Univeristy Hospital, Department of Biomedicine, Aarhus Univeristy. Primary contact, e-mail: britt@biomed.au.dk
  • Annette Raskov Kodahl, Head Consultant, Phase 1 Unit South
  • Estrid Høgdall, Professor, Department of Pathology, Herlev Gentofte Hospital
  • Morten Ladekarl, Professor, Consultant, Department of Oncology, Aalborg university Hospital

Others:

  • Signe Borgquist, Professor, Department Chair, Consultant, Department of Oncology, Aarhus Univeristy Hospital & Clinical Medicine, Aarhus Univeristy
  • Eva Sædder, Cheif Medical Officer, Department of Clinical Pharmacology, Aarhus Univeristy Hospital.
  • Henrik Toft Sørensen, Professor, Department Chair, Department of Clinical Epidemiology, Aarhus University Hospital & Clinical Medicine, Aarhus Univeristy
  • Trine Kjær, Professor, Danish Center for Health Services Research, DaCHE - Danish Centre for Health Economics
  • Karen Lise Garm Spindler, Professor, Consultant, Department of Oncology, Aarhus University Hospital & Clinical Medicine Aarhus Univeristy, AU. Leader of ctDNA RECIST Programme.

Translational group:

  • Søren Vang, Head of Research, Bioinformatics, MOMA, Aarhus University Hospital.
  • Fredrik Otzen, Head of Bioinformatic, Department of Genomic Medicine, Rigshospitalet
  • Maria Rossing, Chief Medical Officer, Department of Genomic Medicine, Rigshospitalet
  • Henrik Hager, Consultant, Department of Pathology, Aarhus University Hospital
  • Ole Halfdan Larsen, Chief Medical Officer, MOMA, Aarhus University Hospital