SDN Biobank : Bioresource of Human Samples Associated with Functional and / or Morphological Bioimaging Results for the Study of Oncological , Cardiological , Neurological , and Metabolic Diseases

SDN Biobank is a not-for-profit service unit. Initially, it was established by the IRCCS SDN in 2012 as a collection of serum and plasma samples from patients who underwent advanced bioimaging exams, such as those performed with Positron Emission Tomography with integrated Magnetic Resonance Imaging ( PET/MRI). In July 2015, SDN Biobank was approved by the local ethics committee to collect human samples from patients affected by oncological, cardiological, neurological, and metabolic diseases when performing diagnostic exams at the IRCCS SDN. All samples are coded and associated with clinical and iconographic documentation related to the performed functional or morphological bioimaging exams. SDN Biobank procedures are carried out according to the ISO 9001 Quality Management System with internal and external audits.

the IRCCS SDN.
(1) Bioresource Overview Project description SDN Biobank was started as a resource center in 2015 with dedicated space and infrastructure at the IRCCS SDN in Naples, Italy.The mission coincides with the institutional role (recognized by the Italian Ministry of Health) of the IRCCS SDN, which is to optimize and improve scientific knowledge in the field of in vivo and in vitro diagnostic integration [1,2].The IRCCS SDN is equipped with cutting-edge technologies that include positron emission tomography with integrated computed tomography (PET/CT) and PET with integrated magnetic resonance imaging (PET/MRI).Additionally, the institute has a proper radiopharmacy for the production and employment of specific radiopharmaceuticals, such as 18 fluorodeoxyglucose (18-FDG), 18-fluorocholine, 18F-di-idrossi-fenilalanina (18F-DOPA), and 18F Florbetapir (Amyvid®).
The SDN Biobank was designed to provide a collection of human biological samples derived from patients affected by oncological, cardiological, neurological, and metabolic diseases, that come to IRCCS SDN for functional and morphological bioimaging exams where the radiotracers reported above are frequently used [3].
The development of the SDN Biobank has been possible thanks to strong collaborations between skilled clinicians, radiologists, pathologists, biochemists, and molecular biologists working at the IRCCS SDN.Actually, the SDN Biobank has recruited approximately 1000 subjects.The majority of these subjects (80%) are patients with oncological diseases, with breast, lung, colon-rectum, and prostate cancer as the most prevalent cases.The remaining portion of the cohort is composed of cardiological (15%) and neurological (5%) patients.For each of the enrolled patients, the clinicaliconographic information is linked to the biological samples collected in the SDN Biobank.Furthermore, the SDN Biobank is a member of the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) with the aim of offering their biological samples to the national and international research community.Spatial coverage: The SDN Biobank is located inside the IRCCS SDN S.p.A. in Via Emanuele Gianturco 113, Naples, Italy.

Temporal coverage
Start date: July 2015.End date: ongoing.

Temporal coverage for accessibility
N/A. (

Steps
To collect biological samples, patients undergoing diagnostic imaging exams are interviewed and recruited before the execution of diagnostic procedure.During the interviews, patients who agree to participate sign a specific written informed consent.Clinical and epidemiological data from the patients are collected by specific medical history forms at the same time.All data are saved and coded to protect patient privacy and confidentiality [4].

Stabilization/preservation
Venous blood samples (15-20 mL) are collected by venipuncture from recruited patients using BD Serum (ref.All instruments used in the SDN Biobank are routinely checked for function and maintenance is performed periodically.

Type of long-term preservation
Vertical ultra-cold temperature freezers and liquid nitrogen dewar.

Storage temperature
Serum and plasma samples are stored in dedicated vertical, ultra-cold freezers (-80°C).Mononuclear cells are stored in vapor-phase liquid nitrogen (-120°C to -150°C) dewars.

Shipping temperature from patient/source to preservation or research use
Transportation from collection sites to the SDN Biobank laboratory occurs at room temperature within 15-20 min of collection.

Shipping temperature from storage to research use
Samples are transported from the SDN Biobank laboratory to research sites on dry-ice in less than 24 hours.

Quality assurance measures
The IRCCS SDN, as well as the SDN Biobank, operates in compliance with the ISO 9001 International Standard for Quality Management System.A quality manual has been prepared that, following a hierarchical structure, includes process maps, process flowcharts, standard operating procedures, records, and forms.Furthermore, the SDN Biobank is subjected to internal and external audits to verify compliance, conformance, and performance with respect to its policy and mission.The staff of the SDN Biobank has been individually trained and each year the staff is updated by participating in annual meetings planned by scientific organizations operating within the field of biobanking, such as the European and Italian node of BBMRI [5].

Source of associated data
Associated data are derived from questionnaires and medical records where co-morbid conditions, such as diabetes, hypertension, tobacco, and alcohol consumption, are reported.Information about patient cancer history and previous bioimaging exams is also registered.

Ethics Statement
Informed consent is obtained using a form approved by the local ethics committee (Comitato Etico IRCCS Pascale -Napoli).In addition, the SDN Biobank operates in compliance with: • The provided samples will be used only for not-for-profit research protocols and will be not sold to third parties.• Research projects in agreement with the SDN Biobank mission will be eligible for sample transfer.• The principal investigator must guarantee proper acknowledgement of the SDN Biobank in any resulting scientific publications.• Payment will be asked for to cover costs of shipping and basic procedures related to the distribution service.
(4) Reuse potential Because the SDN biobank generates multiple aliquots from the same sample, our policy is to not reuse aliquots already sent to research partners, to avoid providing a deteriorated sample due to the freeze-thawing cycles.To allow the research data to be reused for further data analyses, replication of previous findings, or meta-analyses, the SDN biobank requires the results produced by the investigators to be recorded in the electronic database.The reuse of sample-associated data will be possible on a collaborative basis with the permission of the respective principle investigators and the SDN Biobank manager.