PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Exocrine Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [Time frame: Up to 72 months]
Secondary outcome measures (4)
- 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]
- 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]
- Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases [Time frame: Up to 72 months]
- Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases [Time frame: Up to 72 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Léon Bérard — Lyon
Identifiers
NCT: NCT04011982 · ET19-033 (PATAKESS)