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PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Sponsor
Centre Leon Berard (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04011982
Collaborator
(none)
100
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)).

PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors.

    However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available.

    In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors
    Anticipated Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [Up to 36 months]

      Clinical characteristics of patients are consistent with tumor response at each treatment line and disease stage at diagnosis ; Biological characteristics will describe molecular alterations of the tumor by sequencing techniques like Next Generation Sequencing (NGS)

    Secondary Outcome Measures

    1. Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [Up to 36 months]

      Comparative characterization of the different stroma by immunological detection

    2. Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [Up to 36 months]

      Comparative characterization of the different stroma by NGS

    3. Comparison of tumor stroma from primitive tumor versus from metastases [Up to 36 months]

      Comparative characterization of the different stroma by immunological detection

    4. Comparison of tumor stroma from primitive tumor versus from metastases [Up to 36 months]

      Comparative characterization of the different stroma by NGS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female patient 18 age or older

    • Patient operated on for exocrine pancreatic adenocarcinoma at Centre Léon Bérard since 01/01/2010.

    • Histological diagnosis of exocrine pancreatic adenocarcinoma confirmed with surgery specimen.

    Exclusion Criteria:
    • Not applicable

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Leon Berard

    Investigators

    • Principal Investigator: Philippe CASSIER, Centre Leon Berard

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Leon Berard
    ClinicalTrials.gov Identifier:
    NCT04011982
    Other Study ID Numbers:
    • ET19-033 (PATAKESS)
    First Posted:
    Jul 9, 2019
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Leon Berard
    Pancreatic cancer
    Immune infiltrate
    Molecular alterations
    Tumor stroma
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Feb 5, 2020