NCT06552078

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2021

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 Progress51%
Jun 2021Dec 2030

Study Start

First participant enrolled

June 9, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

6.6 years

First QC Date

August 8, 2024

Last Update Submit

April 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers

    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

Eligibility Criteria

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

Patients with biliopancreatic disorders

You may qualify if:

  • age \>= 18 years
  • signed informed consent

You may not qualify if:

  • age \< 18 years
  • unwilling to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS OSpedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* peripheral blood; * portal blood; * saliva; * urine; * stool; * cystic fluid; * pancreatic juice; * biopsy tissue;

MeSH Terms

Conditions

PancreatitisPancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Paolo Giorgio Arcidiacono, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Capurso, MD

CONTACT

Laura Apadula, MSN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 13, 2024

Study Start

June 9, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations