Neuromed- Integrated Health Life Platform and Biobank

Cancer Clinical Trial

— PLATONE  

Official title:

Neuromed- Integrated Health Life Platform and Biobank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279991
• Other study ID #: 51/17
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2023
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: May 30, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Men and women
• Older than 18 years
• Cardiovascular disease
• neurodegenerative disease
• Cancer
• Pregnancy

Exclusion Criteria:

• Inability to understand and to want
• Refusal to sign the informed consent

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Pregnancy

Locations

Country	Name	City	State
Italy	IRCCS INM Neuromed, Department of Epidemiology and Prevention	Pozzilli	IS

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Duffy 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. — View Citation

Fortier 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. — View Citation

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. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Iacoviello 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. — View Citation

Kim 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	baseline
Primary	omics analysis	Measure of genomic, epigenetic and proteomic fingerprint of recruited patients	baseline
Primary	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.	Baseline