Clinical trial NCT05770765: Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
Official title: Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 60000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who access the Department for investigations, analyzes or visits on suspicion 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.

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

• Informed consent (for healthy volounteers also: age \> 18 years, health status ascertained by laboratory tests, electrocardiogram and medical examination)

Exclusion Criteria:

* History of alcohol/drug abuse
* Pregnant or breastfeeding women, unless there are justified and documented needs

Primary outcomes:
measure: Presence of a viral, bacterial or parasitic pathogen
timeFrame: 40 years
Secondary outcomes:
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: