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

February 12, 2024 updated by: Guido Costamagna, Catholic University of the Sacred Heart
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carolina Gualtieri
  • Phone Number: +390630156580

Study Contact Backup

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • "Agostino Gemelli" Hospital, Catholic University of Sacred Heart
        • Contact:
        • Contact:
          • MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Alberto Larghi, MD, Fondazione Policlinico Universitario Agostino Gemelli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDAC AIRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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