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NCT Number: NCT04011982

PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

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.

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Key information

Conditions

Exocrine Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Léon Bérard

Lyon, France

Location status: Recruiting

Location contact

Philippe CASSIER, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer

    Time frame: Up to 72 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 outcomes

  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 72 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 72 months

    Comparative characterization of the different stroma by NGS

  3. Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases

    Time frame: Up to 72 months

    Comparative characterization of the different stroma by immunological detection

  4. Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases

    Time frame: Up to 72 months

    Comparative characterization of the different stroma by NGS

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe CASSIER

CONTACT

[email protected]

04 26 55 68 33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: PATAKESS

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2019
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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