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

Active, not recruiting

• Conditions: Pancreas Cancer

• Registration Number: NCT04246710
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2018-01-28
• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of PDAC molecular subtyping on biopsy samples	At 6 months	Number of patients in whom molecular subtyping on biopsy samples is obtained
Reliability of PDAC molecular subtyping on biopsy samples	At 1 year	concordance between molecular subtyping on biopsy samples and surgery specimens

Secondary Outcome Measures

Name	Time	Method
Progression-free-survival (PFS)	From date of enrollment assessed until death or up to 3 years	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.
Overall survival	From date of enrollment assessed until death or up to 3 years	Overall survival defined as the length of time (in days) between the treatment date and the date of death.

Trial Locations

Locations (1)

Universita' Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy