PACTOL: PAncreatic Disease Cohort of TOuLouse

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05824403
Collaborator
(none)
300
1
46
6.5

Study Details

Study Description

Brief Summary

This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PAncreatic Disease Cohort of TOuLouse
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2026
    Anticipated Study Completion Date :
    Mar 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic tools [3 years after the first inclusion]

      To develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies

    Secondary Outcome Measures

    1. New targets [3 years after the first inclusion]

      To identify new screening targets

    2. Improvement of management [3 years after the first inclusion]

      To improve the management of cystic lesions or Chronic pancreatitis on the decision of therapeutic management

    3. Microbiota [3 years after the first inclusion]

      Study of the microbiota of pancreatic diseases

    4. Clinical data access [3 years after the first inclusion]

      To make available to the scientific community quality material with associated clinical data also of quality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients with inflammatory or cystic exocrine pancreatic pathology

    • Patient able to read and understand the information leaflet

    • Patients who have agreed to participate in the study and have signed the free and informed consent

    • Patients affiliated to a social security system (including AME)

    Exclusion Criteria:
    • Patient with pancreatic cancer pathology

    • Patients with active cancer, whatever the origin

    • Pregnant or breastfeeding patients

    • Patients under legal protection, guardianship or trusteeship

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rangueil hospital Toulouse France

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

    • Principal Investigator: Barbara BOURNET, MD, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT05824403
    Other Study ID Numbers:
    • RC31/22/0530
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 21, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2023