Activation of Biobank Registry for Bilio-pancreatic Diseases (BIO-PANCREAS)

April 30, 2025 updated by: Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele

Activation of Biobank for Association Study Between Environmental and Genetic Factors in Inflammatory, Functional and Neoplastic Bilio-pancreatic Diseases

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Samples collected depending on the disease:

  • Peripheral blood;
  • Portal blood;
  • Saliva;
  • Urine;
  • Stool;
  • Cystic fluid;
  • Pancreatic juice;
  • Biopsy tissue specimens;

Study Type

Observational

Enrollment (Estimated)

2000

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 Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biliopancreatic disorders

Description

Inclusion Criteria:

  • age >= 18 years
  • signed informed consent

Exclusion Criteria:

  • age < 18 years
  • unwilling to sign informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers
Time Frame: 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).
Tthrough study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Paolo Giorgio Arcidiacono, MD, IRCCS Ospedale San Raffaele

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)

June 9, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-PANCREAS

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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