Clinical trial · Observational
EUS-Based Artificial Intelligence to Predict Outcomes in Pancreatic Cancer
An Observational Study on the Application of Artificial Intelligence Model to Predict Diagnosis, Prognosis, and Molecular Alterations in Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| Endoscopic Ultrasound (EUS) | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiomics | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound (EUS), with or without tissue acquisition (EUS-FNA/FNB), performed according to standard clinical practice. No study-specific intervention is introduced. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients who underwent EUS at the Pancreato-Biliary Endoscopy and Endoscopic Ultrasound Unit of
- interventionNames
- Other: Endoscopic ultrasound (EUS), with or without tissue acquisition (EUS-FNA/FNB), performed according to standard clinical practice. No study-specific intervention is introduced.
Primary outcomes (1)
- measure
- Development of an AI algorithm predicting chemotherapy response in patients with pancreatic cancer
- timeFrame
- 6 months
- description
- Development of AI models to predict chemotherapy response in patients with PDAC by evaluating the predictive performance of: 1. An EUS-based AI model (pre-treatment EUS images/videos) 2. A clinical/exposome-based AI model (pre-treatment clinical and laboratory variables) 3. A radiology-based AI model (pre-treatment CT/MRI radiomics) 4. A digital pathology-based AI model (histopathology slides) 5. A multimodal AI model combining all available data sources (EUS + clinical/exposome + CT/MRI radiomics + digital pathology ± molecular data when available) Chemotherapy response will be defined according to radiological response criteria (RECIST) and biochemical response assessed by CA19-9 levels. Model performance will be assessed using AUC-ROC, sensitivity, and specificity.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed diagnosis (final pathology report) of pancreatic cancer obtained through endoscopic ultrasound-guided tissue sampling (EUS-FNA or EUS-FNB) * Age ≥ 18 years at the time of diagnosis * Minimum follow-up duration of 6 months after diagnosis * Absence of other concomitant neoplastic diseases * Age\>= 18 years * Capacity to understand and make informed decisions * Written informed consent provided by the patient Exclusion Criteria: * All patients who underwent endoscopic ultrasound with tissue sampling at the Pancreato-Biliary Endoscopy and Endoscopic Ultrasound Unit of IRCCS San Raffaele Hospital but do not meet the inclusion criteria will be excluded from the final analysis cohorts. * Age\<18 years * Inability to understand and make informed decisions * Refusal to participate in the study
References
Publications (0)
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