PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Exocrine Pancreatic Cancer Clinical Trial

— PATAKESS  

Official title:

PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011982
• Other study ID #: ET19-033 (PATAKESS)
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: April 2028

Study information

• Verified date: April 2023
• Source: Centre Leon Berard
• Contact: Philippe CASSIER
• Phone: 04 26 55 68 33
• Email: philippe.cassier[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exocrine Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer	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)	Up to 72 months
Secondary	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	Comparative characterization of the different stroma by immunological detection	Up to 72 months
Secondary	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	Comparative characterization of the different stroma by NGS	Up to 72 months
Secondary	Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases	Comparative characterization of the different stroma by immunological detection	Up to 72 months
Secondary	Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases	Comparative characterization of the different stroma by NGS	Up to 72 months