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

Study Overview

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

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.

Pancreas Cancer

PDAC-SUBCLASS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-12
First Submitted that Met QC Criteria 2020-01-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-13
First Posted (ACTUAL) 2020-01-29	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Histological diagnoses other than pancreatic ductal adenocarcinoma
Pregnancy or lactation
Unable to sigh informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Medtronic

Investigators

PRINCIPAL_INVESTIGATOR: Alberto Larghi, Fondazione Policlinico Universitario Agostino Gemelli

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record