Clinical trial NCT04011982: PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors
Official title: PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exocrine Pancreatic Cancer
Keywords: Pancreatic cancer
Immune infiltrate
Molecular alterations
Tumor stroma
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on for exocrin pancreatic adenocarcinoma since January 1st, 2010.

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.

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.

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

Primary outcomes:
measure: Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer
timeFrame: Up to 72 months
Secondary outcomes:
measure: 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
timeFrame: Up to 72 months
measure: 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
timeFrame: Up to 72 months
measure: Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases
timeFrame: Up to 72 months
measure: Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Philippe CASSIER
role: PRINCIPAL_INVESTIGATOR
References: