Clinical trial NCT04246710: Pancreatic Cancer Molecular Sub-classification Using Endoscopic Ultrasound Tissue Core Biopsy Samples
Official title: Pancreatic Cancer Molecular Sub-classification for Prognostic Stratification and Individualized Therapy Using Endoscopic Ultrasound Tissue Core Biopsy Samples
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreas Cancer
Keywords: pancreatic cancer
EUS
molecular subtyping
personalized medicine
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-01-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of PDAC molecular subtyping on biopsy samples
timeFrame: At 6 months
measure: Reliability of PDAC molecular subtyping on biopsy samples
timeFrame: At 1 year
Secondary outcomes:
measure: Progression-free-survival (PFS)
timeFrame: From date of enrollment assessed until death or up to 3 years
measure: Overall survival
timeFrame: From date of enrollment assessed until death or up to 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Universita' Cattolica del Sacro Cuore
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Alberto Larghi
role: PRINCIPAL_INVESTIGATOR
References: