San Raffaele IBD Biobank

IBD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071572
• Other study ID #: IBD Biobank
• Status: Recruiting
• Start date: January 18, 2023
• Est. completion date: January 18, 2026

Study information

• Verified date: October 2023
• Source: IRCCS San Raffaele
• Contact: Federica Ungaro
• Phone: 0226437864
• Email: ungaro-federica[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 18, 2026
• Est. primary completion date: January 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with IBD (min 18 years)

Exclusion Criteria:

• Patients without IBD

Related Conditions & MeSH terms

• IBD

Intervention

Other:
• Biological samples collected specifically for the IBD Biobank
Biological samples will include: material intestinal biological waste (surgical leftover), 30 ml of peripheral blood, one sample stool standards and a saliva sample.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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