InfectionsTropicaBiobankNCT05770765
Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
An observational study of Infections, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is the protocol that formalizes the establishment of the TROPICA-BIOBANK biobank Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infections
- How many people
- 60,000 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2019to 30 Oct 2059
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Informed consent (for healthy volounteers also: age > 18 years, health status ascertained by laboratory tests, electrocardiogram and medical examination)
Who cannot join
- History of alcohol/drug abuse
- Pregnant or breastfeeding women, unless there are justified and documented needs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Dora Buonfrate, dora.buonfrate@sacrocuore.it
Zeno Bisoffi
About this study
This is the protocol that formalizes the establishment of the TROPICA-BIOBANK biobank
Read the 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.
- Conditions
- Infections
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a viral, bacterial or parasitic pathogen
Result of laboratory tests on the pathogen responsible for the disease of interest
Measured: 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start30 Oct 2019
- Primary completion30 Oct 2059 (estimated)
- Study completion30 Oct 2059 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770765
- Sponsor's protocol ID
- 2019-46
- Acronym
- TropicaBiobank
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
- ClinicalTrials.gov ID
- NCT05770765
- Acronym / sponsor ID
- TropicaBiobank / 2019-46
- Conditions
- Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Oct 2059 (estimated)
- Study completion
- 30 Oct 2059 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Informed consent (for healthy volounteers also: age > 18 years, health status ascertained by laboratory tests, electrocardiogram and medical examination)
Key exclusion criteria (2 listed)
- History of alcohol/drug abuse
- Pregnant or breastfeeding women, unless there are justified and documented needs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of a viral, bacterial or parasitic pathogen
Time frame: 40 years
Result of laboratory tests on the pathogen responsible for the disease of interest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Related trials for Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a viral, bacterial or parasitic pathogen (time frame: 40 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.