Activation of Biobank Registry for Bilio-pancreatic Diseases

Recruiting

• Conditions: Pancreatic Disease; Pancreatitis; Non-Neoplastic Pancreatic Disorder; Pancreatic Adenocarcinoma

• Registration Number: NCT06552078
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The purpose of establishing the biobank is to create a collection of biological material and clinical data, with a prospective and retrospective mold, in order to investigate the role of genetic predisposition in multifactorial bilio-pancreatic diseases, so that an evaluation of the possible association in the pathogenesis of exogenous factors with endogenous factors can be allowed.

Multifactorial diseases are in fact an expression of genetic predisposition upon which one or more environmental stimuli act. Usually the aforementioned factors are not capable individually of triggering disease but, when simultaneously present, can cause the pathological phenotype. Therefore, it becomes important in the description of disease pathogenesis to identify as many risk factors for disease prevention and early diagnosis.

Detailed Description

Samples collected depending on the disease:

* Peripheral blood;

* Portal blood;

* Saliva;

* Urine;

* Stool;

* Cystic fluid;

* Pancreatic juice;

* Biopsy tissue specimens;

Study Timeline

• Study Start: 2021-06-09
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• age >= 18 years
• signed informed consent

Exclusion Criteria

• age < 18 years
• unwilling to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers	Tthrough study completion, an average of 1 year	The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers will be evaluated by descriptive statistics and when available compared with that of subjects without such disorders (controls).

Trial Locations

Locations (1)

IRCCS OSpedale San Raffaele; 🇮🇹 Milano, Italy