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PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors (PATAKESS)

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ClinicalTrials.gov Identifier: NCT04011982
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

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
Exocrine Pancreatic Cancer

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 36 months ]
    Comparative characterization of the different stroma by NGS

  3. Comparison of tumor stroma from primitive tumor versus from metastases [ Time Frame: Up to 36 months ]
    Comparative characterization of the different stroma by immunological detection

  4. Comparison of tumor stroma from primitive tumor versus from metastases [ Time Frame: Up to 36 months ]
    Comparative characterization of the different stroma by NGS


Biospecimen Retention:   Samples Without DNA
Exocrine pancreatic tumor samples from initial diagnosis biopsy and/or from surgery specimen of primitive tumor and/or from metastases.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients operated on for exocrin pancreatic adenocarcinoma since January 1st, 2010.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011982


Contacts
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Contact: Philippe CASSIER 04 26 55 68 33 philippe.cassier@lyon.unicancer.fr

Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Philippe CASSIER Centre Leon Berard

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04011982     History of Changes
Other Study ID Numbers: ET19-033 (PATAKESS)
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: June 2019

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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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases