Pancreatic Cancer Molecular Sub-classification Using Endoscopic Ultrasound Tissue Core Biopsy Samples

Study Overview
=================
Brief Summary
-----------------
This study evaluated the feasibility and reliability of PDAC molecular subtyping on tissue core biopsies samples acquired under EUS guidance. Moreover, this study will assess the impact of molecular subtypes assessed on EUS-FNB samples in patients with resectable and unresectable (locally advanced, advanced, and metastatic) PDAC undergoing chemotherapy on treatment response and survival and the utility in monitoring disease response to therapy and early occurrence of disease relapse using the TaqMan RNA assay in serum

Detailed Description
-----------------
PDAC patients are categorised as resectable, borderline resectable, locally advanced, metastatic and recurrent. Substantial neoplastic tissue is only available for the resectable group. This is unfortunate as the other groups are those that would benefit the most from molecular characterization and identification of markers, which may be predictive and/or provide therapeutic stratification. For these categories of patients, only fine needle aspiration or small biopsies could be obtained until now. However, the introduction of new needles, specifically designed to acquire larger high quality biopsy samples under endoscopic ultrasound (EUS), has now made it possible to test prognostic, predictive and therapeutic stratification markers. However, the applicability of EUS-fine needle biopsy (EUS-FNB) samples for this purpose has yet to be clinically validated. The working hypothesis of this proposal is that the molecular sub-classification of PDAC on EUS-FNB tissue samples could be applied for prognostic stratification and therapeutic decision strategies in both resectable and unresectable patients using DNA and RNA biomarkers.

Official Title
-----------------
Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples

Conditions
-----------------
Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to EUS with FNB in the suspect of pancreatic cancer Availability of biopsies obtained during EUS-FNB Histological diagnosis of pancreatic ductal adenocarcinoma of any stage Age >18 and <80 years Willing to be followed up at the Fondazione Policlinico A. Gemelli University Hospital Able to sign informed consent Exclusion Criteria: Histological diagnoses other than pancreatic ductal adenocarcinoma Pregnancy or lactation Unable to sigh informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of PDAC molecular subtyping on biopsy samples | Number of patients in whom molecular subtyping on biopsy samples is obtained | At 6 months | 
| Reliability of PDAC molecular subtyping on biopsy samples | concordance between molecular subtyping on biopsy samples and surgery specimens | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free-survival (PFS) | To assess the impact of molecular subtypes assessed on EUS-FNB samples PFS defined as the time from the date of trial entry until disease progression or relapse. | From date of enrollment assessed until death or up to 3 years | 
| Overall survival | Overall survival defined as the length of time (in days) between the treatment date and the date of death. | From date of enrollment assessed until death or up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, EUS, molecular subtyping, personalized medicine