PancreatitisBIO-PANCREASNCT06552078
Activation of Biobank Registry for Bilio-pancreatic Diseases
An observational study of Pancreatitis and Pancreatic Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Pancreatic Disease, Non-Neoplastic Pancreatic Disorder
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biliopancreatic disorders
Who may be able to join
- age >= 18 years
- signed informed consent
Who cannot join
- age < 18 years
- unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS OSpedale San Raffaele
Milan, 20132
Gabriele Capurso, MD, 02/26436548, capurso.gabriele@hsr.it
Laura Apadula, MSN, 02/26433979, apadula.laura@hsr.it
About this study
Official title: 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.
Read the detailed description
Samples collected depending on the disease:
- Peripheral blood;
- Portal blood;
- Saliva;
- Urine;
- Stool;
- Cystic fluid;
- Pancreatic juice;
- Biopsy tissue specimens;
- Conditions
- Pancreatitis, Pancreatic Disease, Non-Neoplastic Pancreatic Disorder, Pancreatic Adenocarcinoma
- Medical subject headings
- Pancreatitis, Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Tthrough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start9 Jun 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
- Investigators
- Paolo Giorgio Arcidiacono, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552078
- Sponsor's protocol ID
- BIO-PANCREAS
- Acronym
- BIO-PANCREAS
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Biobank for Association Study Between Environmental and Genetic Factors in Inflammatory, Functional and Neoplastic Bilio-pancreatic Diseases
- ClinicalTrials.gov ID
- NCT06552078
- Acronym / sponsor ID
- BIO-PANCREAS / BIO-PANCREAS
- Conditions
- Pancreatitis, Pancreatic Disease, Non-Neoplastic Pancreatic Disorder, Pancreatic Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biliopancreatic disorders
Key inclusion criteria (2 listed)
- age >= 18 years
- signed informed consent
Key exclusion criteria (2 listed)
- age < 18 years
- unwilling to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Giorgio Arcidiacono, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis and Pancreatic Disease, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Capurso, MD (02/26436548, capurso.gabriele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.