Creation of a Bank of Biological Materials & Associated Data Related to

Status Recruiting

Clinical Trial Summary

This is the protocol that formalizes the establishment of the TROPICA-BIOBANK biobank

Clinical Trial Description

Subjects who will access the Department of Infectious and Tropical Diseases for investigations, analyzes or visits on suspicion of infectious or tropical disease, hospitalized patients and/or patients participating in proposed clinical trials from the Department will be enrolled. Healthy volunteer donors may also be enrolled. The type of samples collected and stored in the biobank consists of human biological matrices liquids and solids, DNA, protein extracts or subcellular fractions, bacterial isolates and arthropods taken from patients. The collection of samples takes place through the support of various professional figures (doctor, nurse, laboratory technician, biologist/biotechnologist) together with associated data. The samples are de-identified and protected by an encryption system (through the system computer diagnostic data management of the laboratory of the IRCCS Sacro Cuore Don Calabria) and stored at a temperature of -80°C, in the Department's freezers. Samples are stored for 40 years. In order to monitor the quality of the samples over the storage time, a selection of samples used as monthly analytical quality controls will be retested periodically (every 10 years). At the end of the storage time, it will be evaluated whether to extend the storage time of the unused biological samples and associated data or if these will be destroyed. In the first case, an amendment to this Protocol will be submitted to the CESC for approval, in which will specify the duration of the extension of the conservation of the samples and associated data. In the second case, no further data will be collected on the aforementioned samples, without prejudice to their use of those possibly already collected to determine, without altering them, the results of searches already in progress. The samples will in any case be destroyed if they are not in good condition. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05770765
Study type	Observational [Patient Registry]
Source	IRCCS Sacro Cuore Don Calabria di Negrar
Contact	Elvia Malo
Phone	+390456014854
Email	ricerca.clinica@sacrocuore.it
Status	Recruiting
Phase
Start date	October 30, 2019
Completion date	October 30, 2059

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases — TropicaBiobank

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms