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PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04011982
Acronym
PATAKESS
Enrollment
300
Registered
2019-07-09
Start date
2020-09-01
Completion date
2028-04-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine Pancreatic Cancer

Keywords

Pancreatic cancer, Immune infiltrate, Molecular alterations, Tumor stroma

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.

Interventions

None listed

Sponsors

Centre Leon Berard
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancerUp to 72 monthsClinical 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

MeasureTime frameDescription
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 chemotherapyUp to 72 monthsComparative characterization of the different stroma by immunological detection
Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastasesUp to 72 monthsComparative characterization of the different stroma by immunological detection

Countries

France

Contacts

CONTACTPhilippe CASSIER
philippe.cassier@lyon.unicancer.fr04 26 55 68 33
PRINCIPAL_INVESTIGATORPhilippe CASSIER

Centre Leon Berard

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026