PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors (PATAKESS)

April 23, 2026 updated by: Centre Leon Berard

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients operated on for exocrin pancreatic adenocarcinoma since January 1st, 2010.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Up to 72 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Comparative characterization of the different stroma by NGS
Up to 72 months
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
Up to 72 months
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
Up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Leon Berard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe CASSIER, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ET19-033 (PATAKESS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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