COIN: ctDNA on the road to implementation in The Netherlands
By measuring minute amounts of cell-free circulating tumor DNA (ctDNA) in blood plasma via a method called “liquid biopsies”, it now is possible to follow the molecular composition of tumor tissue over time.
Due to its huge potential as diagnostic, prognostic, predictive, and treatment evaluation biomarker, multiple technological platforms to detect ctDNA mutations have been developed over the past years, providing industry standard, proven technology. This technology in principle is suitable for clinical implementation, but validation of clinical utility and analysis of the potential cost effectiveness are largely lacking.
Within the COIN initiative, all relevant disciplines join forces to facilitate the efficient implementation of ctDNA testing in routine clinical practice. The Translational Roadmap for ctDNA implementation shows the steps that need to be taken in this process.
The COIN initiative consists of two parts. Part 1 of COIN will establish an efficient and effective standardized ctDNA biomarker evaluation and adoption procedure, to bring ctDNA applications from uncoordinated anecdotal observations to evidence-based implementation in the Dutch healthcare system. Several currently running observational studies on colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) will serve as use cases. The procedures and models that will be developed along this way, will also serve as a blueprint to speed up the process of implementation of other new biomarkers in the future.
The second part of COIN will demonstrate the value of this blueprint in a ctDNA biomarker-driven intervention trial: MEDOCC-CrEATE. This study aims to establish the clinical value of ctDNA to reduce the risk of under treatment of stage II colorectal cancer. To study the impact of ctDNA diagnostics on cost of drug therapies, compared to Standard of Care (SoC), Health Technology Assessment (HTA) will be an integral part of the project.
