Pancreatic Cancer Evolution Upon Treatment
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fine Needle Biopsy or Aspiration
Sponsored by
About this trial
This is an interventional basic science trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- IRCCS San Raffaele HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Repetition of EUS-FNA or FNB for RNA extraction
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05195281
Brief Title
Pancreatic Cancer Evolution Upon Treatment
Official Title
Pancreatic Cancer Evolution Upon Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repetition of EUS-FNA or FNB for RNA extraction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fine Needle Biopsy or Aspiration
Intervention Description
A new sampling of the tumor will be performed after 4-6 months of neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
Evaluation of molecular subtype modification
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Livia Archibugi, MD
Phone
+39-02-26432471
Email
archibugi.livia@hsr.it
Facility Information:
Facility Name
IRCCS San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livia Archibugi, MD
Phone
+39-02-26432471
Email
archibugi.livia@hsr.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pancreatic Cancer Evolution Upon Treatment
We'll reach out to this number within 24 hrs