Pancreatic Cancer Evolution Upon Treatment

NCT05195281 | Recruiting DMC

• 1 other identifier: PACEUT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of molecular subtype modification

  As all patients are having baseline (at diagnosis) molecular subtype (classical or basal-like) evaluation through RNAsequencing, patients enrolled in the PACEUT trial will undergo a new evaluation of the molecular subtype (based on RNAsequencing performed on the EUS-FNA or FNB) and evaluation of gene expression

  6 months

Study Arms (1)

Repetition of EUS-FNA or FNB for RNA extraction

EXPERIMENTAL

Procedure: Fine Needle Biopsy or Aspiration

Interventions

Fine Needle Biopsy or Aspiration PROCEDURE

A new sampling of the tumor will be performed after 4-6 months of neoadjuvant chemotherapy

Repetition of EUS-FNA or FNB for RNA extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Willing to sign informed consent
• Patient with CT scan or MRI or EUS defining the lesion as locally advanced
• Patient who already underwent EUS-TA for solid lesion of the pancreas positive for pancreatic ductal adenocarcinoma (PDAC)
• Patient undergoing neoadjuvant chemotherapy
• Patient primarily followed at San Raffaele Hospital

You may not qualify if:

• Patients not willing to sign informed consent
• Pregnancy and breastfeeding
• Cytology positive for malignancies other than PDAC
• Patient undergoing progression at re-staging CT scan

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Central Study Contacts

Livia Archibugi, MD

CONTACT

+39-02-26432471; archibugi.livia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Clinical Research, PancreatoBiliary Endoscopy and EUS Division, Deputy Director of Pancreas Center

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 18, 2022
• Study Start: July 14, 2021
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

IT (1)