San Raffaele IBD Biobank

San Raffaele IBD Biobank: Accelerating Research From the Bed to the Bench Side

The developments of knowledge and possibilities of investigation in the biomedical field, and in particularly in the field of inflammatory bowel diseases need to be analyzed and study vast cases of biological material carefully collected, preserved and correlated with complete clinical-pathological-instrumental data. In order to organize and make uniform the collection, storage and management of samples and the clinical data associated with them, a biobank is being set up, called "IBD Biobank" aimed at studying inflammatory intestinal diseases. THE subjects/patients who decide to authorize the collection, storage and use of biological material for future research purposes which are not currently identifiable will be called, in this document, donors. The IBD Biobank involves the recruitment of adult subjects. To each donor will be given informed consent DSAN 1178/6 ("Regulation e informed consent for the collection, conservation and use of human biological material spontaneous monocentric or multicentric studies with promoting OSR") or the most updated version of this informed consent, according to the directives of the OSR Ethics Committee. The biological material of the IBD Biobank will be processed at the laboratories of the Biological Resources Center (CRB) e preserved at BIOREP srl (Via Olgettina, 60, c/o San Raffaele Hospital-DIBIT2 - Palazzina San Michele 20132 Milan). Generally biological materials will be collected during the already scheduled surgery and the routine clinical examination as part of outpatient visits, day hospitals and hospital admissions. The biological samples will come stored in tubes equipped with barcode identification (2D) which guarantee a code unique to each rate and preserve its anonymity. The clinical-pathological-instrumental data, demographic and anamnestic information will be entered by trained personnel on a computerized database anonymously by assigning a UPN code identifying the patient. Access the database is managed via personal login and password. All data entered is recorded and stored on the server of the IRCCS San Raffaele Hospital in Milan.

Study Overview

• Status: Recruiting
• Conditions: IBD
• Intervention / Treatment: Other: Biological samples collected specifically for the IBD Biobank

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Federica Ungaro; Phone Number: 0226437864; Email: ungaro-federica@hsr.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Federica Ungaro, PhD; Phone Number: 0226437864; Email: ungaro.federica@hsr.it
    • Principal Investigator: Silvio Danese, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

We will enroll Patients with IBD affering to OSR

Description

Inclusion Criteria:

• Patients with IBD (min 18 years)

Exclusion Criteria:

• Patients without IBD

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To perform DNA, RNA and protein extraction, cell isolation, serum isolation and metabolomic analysis from IBD patients blood, tissue, feces and saliva	In particular, the analysis are: Tissue: DNA, RNA and protein extraction, cell isolation Blood: DNA, RNA and protein extraction, cell isolation and serum isolation Feces: DNA and RNA extraction, metabolomic analysis Saliva: DNA and RNA extraction	1-36

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): January 18, 2026
• Study Completion (Estimated): January 18, 2026

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IBD Biobank

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No