Working Group 2
Non-invasive Biomarkers
This WG will apply state-of-the-art liquid biopsies for the detection and characterization of circulating tumor cells (CTCs) and DNA (ctDNA), tumor-derived exosomes, tumor-educated platelets (TEP) and epigenetic markers and will test their diagnostic value for IPMNs and early-stage PDACs.


Objectives
- To establish a set of validated SOPs that can be used to assess circulating biomarkers from patients with PDACs and IPMNs.
- To apply liquid biopsy SOPs to improve PDAC screening, diagnosis, and monitoring.
- To evaluate different systems and protocols for detection and characterization of PDAC and CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- To develop SOPs for detection of PDAC and IPMNs CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- To create an infrastructure for multi-center trials and trainings to ensure compliance and performance of SOPs and to set criteria for assessing quality of clinical samples.
- To detect and characterize CTCs, ctDNA, exosomes, TEPs and epigenetic markers in a multi-centric setup in defined sets of patients with PDAC and IPMNs, pancreatitis and controls.
- To compare data from CTCs, ctDNA, exosomes, TEPs and epigenetic markers with clinical information derived from conventional diagnostic tools.
- To evaluate individual and multiple blood-based biomarkers for PDAC diagnostic and monitoring.
- To evaluate the value of blood-based biomarkers as companion to the existing conventional diagnostic tools.
- Implementation of AI approaches in the optimization of all the above tasks.

Tasks

Activities
Dedicated WG meetings will take place (1-2 per year). Workshops on the field will be included during meetings. A training school will be committed to the topic of non-invasive biomarkers. Interlaboratory exchanges in the form of STSMs are also envisioned especially for young researchers. A tight monitoring of the WG activities will be ensured by a strong WG committee.
- Comparison of a pre-defined set of technologies and protocols for detection and characterization of PDAC and IPMN CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- Establishment of consensual SOPs for detection and characterization of PDAC and IPMN CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- Multi-centric comparison of SOPs.
- Establishment of criteria and cut-offs to classify samples according to their tumor content.

Milestones

Objectives
- To establish a set of validated SOPs that can be used to assess circulating biomarkers from patients with PDACs and IPMNs.
- To apply liquid biopsy SOPs to improve PDAC screening, diagnosis, and monitoring.

Tasks
- To evaluate different systems and protocols for detection and characterization of PDAC and CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- To develop SOPs for detection of PDAC and IPMNs CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- To create an infrastructure for multi-center trials and trainings to ensure compliance and performance of SOPs and to set criteria for assessing quality of clinical samples.
- To detect and characterize CTCs, ctDNA, exosomes, TEPs and epigenetic markers in a multi-centric setup in defined sets of patients with PDAC and IPMNs, pancreatitis and controls.
- To compare data from CTCs, ctDNA, exosomes, TEPs and epigenetic markers with clinical information derived from conventional diagnostic tools.
- To evaluate individual and multiple blood-based biomarkers for PDAC diagnostic and monitoring.
- To evaluate the value of blood-based biomarkers as companion to the existing conventional diagnostic tools.
- Implementation of AI approaches in the optimization of all the above tasks.

Activities
Dedicated WG meetings will take place (1-2 per year). Workshops on the field will be included during meetings. A training school will be committed to the topic of non-invasive biomarkers. Interlaboratory exchanges in the form of STSMs are also envisioned especially for young researchers. A tight monitoring of the WG activities will be ensured by a strong WG committee.

Milestones
- Comparison of a pre-defined set of technologies and protocols for detection and characterization of PDAC and IPMN CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- Establishment of consensual SOPs for detection and characterization of PDAC and IPMN CTCs, ctDNA, exosomes, TEPs and epigenetic markers.
- Multi-centric comparison of SOPs.
- Establishment of criteria and cut-offs to classify samples according to their tumor content.