Cardiovascular DiseasesPLATONENCT03279991
Neuromed- Integrated Health Life Platform and Biobank
An observational study of Cardiovascular Diseases and Neuro-Degenerative Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiovascular Diseases, Neuro-Degenerative Disease, Cancer
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2019to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in the Neuromed group clinics who will have signed informed consent
Who may be able to join
- Men and women
- Older than 18 years
- Cardiovascular disease
- neurodegenerative disease
- Cancer
- Pregnancy
Who cannot join
- Inability to understand and to want
- Refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS INM Neuromed, Department of Epidemiology and Prevention
Pozzilli, IS, 86077
About this study
This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.
Read the detailed description
There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.
An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.
The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.
- Conditions
- Cardiovascular Diseases, Neuro-Degenerative Disease, Cancer, Pregnancy
- Keywords
- biobank, chronic disease, omics, big data, 4 P medicine
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological sample bank
A repository of biological samples, "Neurobiobank", from patients who will join the project, will be organised at the biotechnology park of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed of Pozzilli under the responsibility of the experienced staff at the Department of Epidemiology and Prevention.
Measured: baseline
Integrated health-life big data platform
Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.
Measured: baseline
omics analysis
Measure of genomic, epigenetic and proteomic fingerprint of recruited patients
Measured: baseline
Four P (4P) medicine
Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start4 Mar 2019
- Primary completion27 Feb 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cross-sectional
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Iacoviello, Neuromed IRCCS
- Investigators
- licia Iacoviello, MD, PhD, Study chair, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279991
- Sponsor's protocol ID
- 51/17
- Acronym
- PLATONE
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2017
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
Publications
GBD 2015 SDG Collaborators. Measuring the health-related Sustainable Development Goals in 188 countries: a baseline analysis from the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1813-1850. doi: 10.1016/S0140-6736(16)31467-2. Epub 2016 Sep 21.
PubMed 27665228Iacoviello L, De Curtis A, Donati MB, de Gaetano G. Biobanks for cardiovascular epidemiology and prevention. Future Cardiol. 2014 Mar;10(2):243-54. doi: 10.2217/fca.13.110.
PubMed 24762252Fortier I, Doiron D, Burton P, Raina P. Invited commentary: consolidating data harmonization--how to obtain quality and applicability? Am J Epidemiol. 2011 Aug 1;174(3):261-4; author reply 265-6. doi: 10.1093/aje/kwr194. Epub 2011 Jul 11.
PubMed 21749975Kim DH, Kim YS, Son NI, Kang CK, Kim AR. Recent omics technologies and their emerging applications for personalised medicine. IET Syst Biol. 2017 Jun;11(3):87-98. doi: 10.1049/iet-syb.2016.0016.
PubMed 28518059Duffy MJ, O'Donovan N, McDermott E, Crown J. Validated biomarkers: The key to precision treatment in patients with breast cancer. Breast. 2016 Oct;29:192-201. doi: 10.1016/j.breast.2016.07.009. Epub 2016 Aug 9.
PubMed 27521224
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromed- Integrated Health Life Platform and Biobank
- ClinicalTrials.gov ID
- NCT03279991
- Acronym / sponsor ID
- PLATONE / 51/17
- Conditions
- Cardiovascular Diseases, Neuro-Degenerative Disease, Cancer, Pregnancy
- Keywords
- biobank, chronic disease, omics, big data, 4 P medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 12 Sep 2017 (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 project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.
Detailed description
There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.
An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.
The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the Neuromed group clinics who will have signed informed consent
Key inclusion criteria (6 listed)
- Men and women
- Older than 18 years
- Cardiovascular disease
- neurodegenerative disease
- Cancer
Key exclusion criteria (2 listed)
- Inability to understand and to want
- Refusal to sign the informed consent
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
Biological sample bank
Time frame: baseline
A repository of biological samples, "Neurobiobank", from patients who will join the project, will be organised at the biotechnology park of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed of Pozzilli under the responsibility of the experienced staff at the Department of Epidemiology and Prevention.
Integrated health-life big data platform
Time frame: baseline
Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.
omics analysis
Time frame: baseline
Measure of genomic, epigenetic and proteomic fingerprint of recruited patients
Four P (4P) medicine
Time frame: Baseline
Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 27665228GBD 2015 SDG Collaborators. Measuring the health-related Sustainable Development Goals in 188 countries: a baseline analysis from the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1813-1850. doi: 10.1016/S0140-6736(16)31467-2. Epub 2016 Sep 21.
- Background: PubMed 24762252Iacoviello L, De Curtis A, Donati MB, de Gaetano G. Biobanks for cardiovascular epidemiology and prevention. Future Cardiol. 2014 Mar;10(2):243-54. doi: 10.2217/fca.13.110.
- Background: PubMed 21749975Fortier I, Doiron D, Burton P, Raina P. Invited commentary: consolidating data harmonization--how to obtain quality and applicability? Am J Epidemiol. 2011 Aug 1;174(3):261-4; author reply 265-6. doi: 10.1093/aje/kwr194. Epub 2011 Jul 11.
- Background: PubMed 28518059Kim DH, Kim YS, Son NI, Kang CK, Kim AR. Recent omics technologies and their emerging applications for personalised medicine. IET Syst Biol. 2017 Jun;11(3):87-98. doi: 10.1049/iet-syb.2016.0016.
- Background: PubMed 27521224Duffy MJ, O'Donovan N, McDermott E, Crown J. Validated biomarkers: The key to precision treatment in patients with breast cancer. Breast. 2016 Oct;29:192-201. doi: 10.1016/j.breast.2016.07.009. Epub 2016 Aug 9.
- Individual participant dataSharing planned: Yes. submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
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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. This study is not recruiting at the moment.
licia Iacoviello, MD, PhD study chair
IRCCS Neuromed
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 Cardiovascular Diseases and Neuro-Degenerative Disease, run by Neuromed IRCCS 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 6 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: finished, as of the sponsor's last update on 14 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological sample bank (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279991, which also lists 5 linked publications.
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 14 Nov 2023.