About this trial
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
Availability of biopsies obtained during EUS-FNB
Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
Patients must be fit for chemotherapy administration
Disqualifiers
Histological diagnoses other than pancreatic ductal adenocarcinoma
Pregnancy or lactation
Trial population
This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Progression-free-survival (PFS)
To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.
Overall survival
To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.
Sponsors and contacts
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