NCT05824403

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2023Dec 2027

First Submitted

Initial submission to the registry

March 27, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

March 27, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

Pancreatic cystAcute pancreatitischronic pancreatitisIntra Pancreatic Mucinous Neoplasiadiagnosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic tools

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

    3 years after the first inclusion

Secondary Outcomes (4)

  • New targets

    3 years after the first inclusion

  • Improvement of management

    3 years after the first inclusion

  • Microbiota

    3 years after the first inclusion

  • Clinical data access

    3 years after the first inclusion

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic disease

You may qualify if:

  • 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)

You may not qualify if:

  • Patient with pancreatic cancer pathology
  • Patients with active cancer, whatever the origin
  • Pregnant or breastfeeding patients
  • Patients under legal protection, guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rangueil hospital

Toulouse, France

RECRUITING

Related Publications (1)

  • Bardol T, Dujon AM, Taly V, Dunyach-Remy C, Lavigne JP, Costa-Silva B, Kurma K, Eslami-S Z, Cayrefourcq L, Canivet C, Muscari F, Bournet B, Alix-Panabieres C. Early detection of pancreatic cancer by liquid biopsy "PANLIPSY": a french nation-wide study project. BMC Cancer. 2024 Jun 10;24(1):709. doi: 10.1186/s12885-024-12463-8.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and tissues

MeSH Terms

Conditions

Pancreatic DiseasesPancreatic CystPancreatitisPancreatitis, ChronicDisease

Condition Hierarchy (Ancestors)

Digestive System DiseasesCystsNeoplasmsChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara BOURNET, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 21, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations