Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05195281

Pancreatic Cancer Evolution Upon Treatment

Led by IRCCS San Raffaele · Updated on 2026-01-15

80

Participants Needed

1

Research Sites

337 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project aims at evaluating the different subtypes of pancreatic cancer on EUS-tissue acquisition of pancreatic cancer patients, and their possible modifications throughout time. The study takes advantage of a systematic evaluation of pancreatic cancers through diagnostic EUS-guided fine needle biopsy (FNB) sampling of the mass performed during a restaging EUS. FNB samples represent a valuable source of cancer cells, both for the histological diagnosis and as the source of tumor macromolecules, including DNA and RNA. Study design This is a prospective study enrolling patients with non-metastatic pancreatic cancer who already underwent diagnostic EUS with tissue acquisition and rapid on-site evaluation (ROSE) by cytologist positive for pancreatic cancer, with a first sample acquired for diagnostic purposes and a second sample stored for RNA extraction acquired with the already approved protocol BIOGASTRO. As recommended by guidelines, patients will follow the standard pathway of treatment, being sent to chemotherapy and will then undergo restaging of the lesion and re-evaluation of vascular invasion by CT and EUS. During this second session of EUS a new specimen of the tumor will be sampled for diagnostic purposes, with a second pass undergoing for RNA extraction.

CONDITIONS

Official Title

Pancreatic Cancer Evolution Upon Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Willing to sign informed consent
  • Diagnosis of locally advanced pancreatic cancer confirmed by CT scan, MRI, or EUS
  • Previously had EUS-guided tissue acquisition positive for pancreatic ductal adenocarcinoma
  • Currently undergoing neoadjuvant chemotherapy
  • Primarily followed at San Raffaele Hospital
Not Eligible

You will not qualify if you...

  • Unwilling to sign informed consent
  • Pregnancy or breastfeeding
  • Cytology positive for malignancies other than pancreatic ductal adenocarcinoma
  • Disease progression observed at re-staging CT scan

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele Hospital

Milan, Italy, 20132

Actively Recruiting

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Research Team

L

Livia Archibugi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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