PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

NCT04011982 | Recruiting

• 1 other identifier: ET19-033 (PATAKESS)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Exocrine Pancreatic Cancer

Keywords

Pancreatic cancer; Immune infiltrate; Molecular alterations; Tumor stroma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  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

  Up to 72 months

• Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases

  Up to 72 months

• Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases

  Up to 72 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Exocrine pancreatic tumor samples (from initial diagnosis biopsy and/or from surgery specimen of primitive tumor and/or from metastases) and blood sample (collected during a routine check-up)

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Philippe CASSIER

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CASSIER

CONTACT

04 26 55 68 33; philippe.cassier@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 9, 2019
• Study Start: September 1, 2020
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

FR (1)