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NCT Number: NCT05195281

Pancreatic Cancer Evolution Upon Treatment

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine Needle Biopsy or Aspiration

Procedure

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

Primary outcomes

  1. Evaluation of molecular subtype modification

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Livia Archibugi, MD

CONTACT

[email protected]

+39-02-26432471

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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