Pancreatic Cancer Evolution Upon Treatment

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT05195281
Collaborator
(none)
80
1
1
41.6
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fine Needle Biopsy or Aspiration
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pancreatic Cancer Evolution Upon Treatment
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Repetition of EUS-FNA or FNB for RNA extraction

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS San Raffaele Hospital Milan Italy 20132

Sponsors and Collaborators

  • IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gabriele Capurso, Chief of Clinical Research, PancreatoBiliary Endoscopy and EUS Division, Deputy Director of Pancreas Center, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT05195281
Other Study ID Numbers:
  • PACEUT
First Posted:
Jan 18, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022