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

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Recruiting
CT.gov ID
NCT05248750
Collaborator
(none)
250
Enrollment
1
Location
59.6
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
    Actual Study Start Date :
    Jul 22, 2021
    Anticipated Primary Completion Date :
    Jul 10, 2024
    Anticipated Study Completion Date :
    Jul 10, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 "Agostino Gemelli" Hospital, Catholic University of Sacred Heart Rome Lazio Italy 00168

    Sponsors and Collaborators

    • Catholic University of the Sacred Heart

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guido Costamagna, Professor, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT05248750
    Other Study ID Numbers:
    • PDAC AIRC
    First Posted:
    Feb 21, 2022
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guido Costamagna, Professor, Catholic University of the Sacred Heart
    pancreatic cancer
    endoscopic ultrasound (EUS)
    personalized medicine
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2022