Neuromed- Integrated Health Life Platform and Biobank

Completed

• Conditions: Cardiovascular Diseases; Cancer; Neuro-Degenerative Disease; Pregnancy

• Registration Number: NCT03279991
• Lead Sponsor: Neuromed IRCCS

Brief 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.

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 Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2019-03-04
• Primary Completion: 2023-02-27
• Study Completion: 2023-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-11
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biological sample bank	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.
omics analysis	baseline	Measure of genomic, epigenetic and proteomic fingerprint of recruited patients
Four P (4P) medicine	Baseline	Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.
Integrated health-life big data platform	baseline	Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.

Trial Locations

Locations (1)

IRCCS INM Neuromed, Department of Epidemiology and Prevention; 🇮🇹 Pozzilli, IS, Italy