This clinical trial aims to learn if a multimodal artificial intelligence (AI) model can enhance the diagnosis of pancreatic solid lesions. The main questions it aims to answer are:
1. Does the AI model enhance the diagnostic performance of endoscopists in diagnosing pancreatic solid lesions?
2. Does the addition of interpretability analysis further improve the diagnostic performance of the assisted endoscopists? Researchers will compare the diagnostic performance of endoscopists with or without the assistance of the AI model.
Participants will:
1. Their clinical data will be prospectively collected.
2. They will be randomized to the AI-assist group and the conventional diagnosis group.
BACKGROUND: The diagnosis of pancreatic adenocarcinoma (PDAC) in many cases is completely unforeseen by the patient, who often faces a disease that is already at an advanced stage, with poor prognosis. The clinical visit during which the diagnosis is communicated together with the first information regarding the planned treatments is of paramount importance. It is hypothesized that the clarity of such information is able to influence patients's engagement and thus the compliance.
AIMS: The aim of this study is to collect quantitative data on the level of PDAC patient engagement and the rate of understanding of the information received from the doctor, and investigate the possible association between these two variables and with the patient's level of compliance.
METHODS: This is a single-center, observational, cross-sectional cohort study focused on patients diagnosed with PDAC, approved by the Ethics Committee of the San Raffaele Hospital. As no preliminary data are available on the association between PDAC patient's understanding rate and their level of engagement and of compliance no power calculation is possible. This is a pilot study, aimed at enrolling at least 45 PDAC patients during a 3 months frame.
CONCLUSION: COMMUNI.CARE will be the first study specifically investigating whether there is a relation between PDAC patients' rate of understanding, their engagement and compliance at time of diagnosis.
We are going to establish "organoid" models from pancreatic cancer biopsies achieved via EUS-FNA. Then the sensitivity of the selected FDA-approved anti-cancer drugs will be tested in these organoids.
Creation of a collection of blood samples that will be collected before and then under treatment in patients with digestive adenocarcinoma during the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.
Primary Objectives:
-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.
Secondary Objectives:
* Determine the progression-free survival (PFS).
* Determine the response rate (RR).
A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.
The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas.
Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase.
The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body.
Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).
The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.
The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are:
* Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time?
* What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.
