Circular DNA in screening and prognosis of pancreatic cancer

Informazioni relative al progetto

CIRCULAR VISION 2.0

ID dell’accordo di sovvenzione: 101213445

DOI

10.3030/101213445

Data della firma CE 28 Aprile 2025

Data di avvio 1 Giugno 2025

Data di completamento 30 Novembre 2027

Finanziato da

• The European Innovation Council (EIC)

Costo totale

Nessun dato

Contributo UE

€ 2 499 824,00

Coordinato da

KOBENHAVNS UNIVERSITET
Denmark

Periodic Reporting for period 1 - CIRCULAR VISION 2.0 (Circular DNA in screening and prognosis of pancreatic cancer)

Periodo di rendicontazione: 2025-06-01 al 2026-05-31

Sintesi del contesto e degli obiettivi generali del progetto

Pancreatic cancer is one of the deadliest cancers, mainly because it is usually diagnosed at a late stage when treatment options are limited. The five-year survival rate remains very low, highlighting an urgent need for new approaches that enable earlier detection and intervention. Improving early diagnosis is therefore a key challenge in cancer care and aligns with European priorities on cancer prevention, early detection, and reducing mortality.
This project builds on the discovery of a novel blood-based biomarker—circular DNA. The overall objective is to develop an innovative diagnostic software solution that uses this biomarker to accurately classify individuals as having or not having cancer, enabling minimally invasive detection of pancreatic cancer from blood samples.
The project follows a clear pathway to impact: advancing a scientific breakthrough into a clinically and commercially viable solution. This includes optimizing laboratory methods, developing robust computational tools, and preparing for regulatory approval and market entry. By bridging the gap between research and application, the project aims to contribute to earlier diagnosis, improved patient outcomes, and more efficient healthcare systems across

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During the first year, the project has focused on advancing both the experimental and computational components of the technology.
Significant progress has been made in optimizing the purification of circular DNA from blood plasma. The method has been tested on plasma volumes ranging from 1 mL to 5 mL, with further work ongoing to confirm its applicability and consistency across different sample volumes.
In parallel, the project has generated a substantial dataset through the extraction and sequencing of biological material from pancreatic cancer patients. This includes plasma samples from 321 patients and tumor samples from 50 patients, bringing the database total to 1,308 processed patient plasma samples, providing a strong foundation for biomarker validation and algorithm development.
On the computational side, a new and improved version of the Circle-Map 2.0 analysis software has been developed. This proprietary tool addresses performance limitations of earlier versions and aims to improve the accuracy and robustness of circular DNA detection and profiling.
The project has also explored pathways for scaling and automation of the laboratory workflow. Visits to specialized facilities and engagement with external experts have helped identify potential solutions for automating the process, which is essential for future clinical and commercial deployment.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

The project goes beyond the current state of the art by introducing a novel approach to early cancer detection based on circular DNA, a biomarker that has not yet been exploited in clinical diagnostics. This approach has the potential to achieve higher sensitivity and specificity compared to existing methods, particularly for early-stage pancreatic cancer where current diagnostic tools are limited.
The integration of optimized laboratory techniques, large-scale clinical datasets, and improved computational tools represents a significant advancement over existing diagnostic workflows. In particular, the development of Circle-Map 2.0 enhances the accuracy and scalability of circular DNA analysis, supporting its application in real-world clinical settings.
The expected impact of these results includes earlier detection of pancreatic cancer, improved patient stratification, and ultimately better survival outcomes. In addition, the technology has potential applications beyond pancreatic cancer, opening new avenues for broader cancer diagnostics.
To ensure further uptake and success, several key steps are required. These include large-scale clinical validation, further development of automated workflows, and progression through regulatory approval processes under the In Vitro Diagnostic Regulation (IVDR). Access to investment and partnerships with healthcare providers and industry will be essential to support commercialization. The development of standards and guidelines for diagnostics will also play an important role in enabling widespread adoption.