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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05248750

Enrollment

250

Registered

2022-02-21

Start date

2021-07-22

Completion date

2026-07-10

Last updated

2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Keywords

pancreatic cancer, endoscopic ultrasound (EUS), personalized medicine

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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 * They have to express their willingness to be followed up at our pancreatic high volume centers * Age \>18 and \<80 years * Able to sign informed consent

Exclusion criteria

* Histological diagnoses other than pancreatic ductal adenocarcinoma * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame	Description
Progression-free-survival (PFS)	From date of enrollment assessed until death or up to 2 years	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	From date of enrollment assessed until death or up to 2 years	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.

Countries

Italy

Contacts

Primary ContactAlberto Larghi, MD

alberto.larghi@yahoo.it+390630156580

Backup ContactCarolina Gualtieri

+390630156580

Outcome results