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

NCT04246710 | Active Not Recruiting

• 1 other identifier: PDAC-SUBCLASS
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreas Cancer

Keywords

pancreatic cancer; EUS; molecular subtyping; personalized medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Progression-free-survival (PFS)

  From date of enrollment assessed until death or up to 3 years

• Overall survival

  From date of enrollment assessed until death or up to 3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Medtronic: collaborator

Study Sites (1)

Universita' Cattolica del Sacro Cuore

Rome, 00136, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

sequencing on DNA from paraffin tissues will be performed to examine the mutational and copy number status of 87 genes

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alberto Larghi

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 29, 2020
• Study Start: January 28, 2018
• Primary Completion: June 1, 2024
• Study Completion: June 2, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)