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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Catholic University of the Sacred Heart
Updated on 19 February 2024
cancer
adenocarcinoma
core needle biopsy
endoscopic ultrasound
pdac
pancreatic ductal adenocarcinoma
breast ductal carcinoma

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

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.

Details
Condition Pancreatic Cancer, Pancreatic Cancer
Age 18years - 80years
Clinical Study IdentifierNCT04246710
SponsorCatholic University of the Sacred Heart
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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