Clinical Research Directory

EUS-Based Artificial Intelligence to Predict Outcomes in Pancreatic Cancer

Sponsor: IRCCS San Raffaele

Summary

The EUS-AI-R study is an observational, single-center, two-phase (retrospective-prospective) study designed to develop and validate artificial intelligence (AI) models for predicting chemotherapy response and oncological outcomes in patients with pancreatic ductal adenocarcinoma (PDAC). Patients who underwent endoscopic ultrasound (EUS) with tissue acquisition (EUS-FNA/FNB) for suspected pancreatic lesions at IRCCS San Raffaele Hospital between January 1st, 2019 and January 2026 will be retrospectively included. All patients have a histologically confirmed diagnosis of PDAC and a minimum follow-up of six months. These data derive from an IRB-approved institutional study (BIOPANCREAS; NCT06552078). Retrospective multimodal data, including EUS imaging (B-mode, elastography, contrast-enhanced EUS), clinical and laboratory variables, CT/MRI imaging, digital pathology, and molecular data when available, will be used to develop and internally validate multiple AI models. In the prospective phase, the best-performing AI model will be applied to an independent cohort of patients undergoing EUS at the same institution to evaluate feasibility, calibration, and real-world performance. No additional procedures beyond standard clinical practice will be performed.

Official title: An Observational Study on the Application of Artificial Intelligence Model to Predict Diagnosis, Prognosis, and Molecular Alterations in Pancreatic Cancer

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