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

Recruiting

• Conditions: Pancreas Cancer

• Registration Number: NCT05248750
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-22
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-07-10
• Study Completion: 2026-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

"Agostino Gemelli" Hospital, Catholic University of Sacred Heart; 🇮🇹 Rome, Lazio, Italy