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Clinical Trials in Italy / NCT05195281
Recruiting Not applicable

Pancreatic Cancer Evolution Upon Treatment

NCT05195281 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Not applicable
Started
2021-07-14
Last updated
2026-01-15

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Fine Needle Biopsy or Aspiration

Fine Needle Biopsy or Aspiration: A new sampling of the tumor will be performed after 4-6 months of neoadjuvant chemotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Evaluation of molecular subtype modification — 6 months
    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

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Hospital Milan Italy Recruiting

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Other trials for the same condition

PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum) Starting soon
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting
Prehabilitation in Pancreatic Surgery Recruiting
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma Starting soon
Radiology Registry on Pancreatic Malignancies Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05195281 on ClinicalTrials.gov ↗ ← All trials in Italy