Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCatholic University of the Sacred Heart

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
From date of enrollment assessed until death or up to 2 years
2

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.

Time frame
From date of enrollment assessed until death or up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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