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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreas Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00136
    • Universita' Cattolica del Sacro Cuore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with resectable disease and those with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, advanced, and metastatic.

Description

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

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Medtronic
• Investigators: Principal Investigator: Alberto Larghi, Fondazione Policlinico Universitario Agostino Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 2, 2024

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pancreatic cancer; EUS; personalized medicine; molecular subtyping
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PDAC-SUBCLASS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No