Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06071572
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-25
Brief Title:
San Raffaele IBD Biobank
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
San Raffaele IBD Biobank Accelerating Research From the Bed to the Bench Side
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjectspatients 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 11786 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 co 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None