NCT07803770Not yet recruiting
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 · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Pancreatic cancer
- NCT number
- NCT07803770
What you commit to
- Study type: Observational
- Planned participants: 700
- From 31 Oct 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age\<18 years
Other
- 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.
- Inability to understand and make informed decisions
- Refusal to participate in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.