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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04246710
• Other study ID #: PDAC-SUBCLASS
• Status: Active, not recruiting
• Start date: January 28, 2018
• Est. completion date: June 2, 2024

Study information

• Verified date: February 2024
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 2, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Italy	Universita' Cattolica del Sacro Cuore	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Medtronic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of PDAC molecular subtyping on biopsy samples	Number of patients in whom molecular subtyping on biopsy samples is obtained	At 6 months
Primary	Reliability of PDAC molecular subtyping on biopsy samples	concordance between molecular subtyping on biopsy samples and surgery specimens	At 1 year
Secondary	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
Secondary	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