PLATONE: Neuromed- Integrated Health Life Platform and Biobank

Sponsor
Neuromed IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT03279991
Collaborator
(none)
120,000
1
47.8
2508.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    120000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Neuromed- Integrated Health Life Platform and Biobank
    Actual Study Start Date :
    Mar 4, 2019
    Anticipated Primary Completion Date :
    Feb 27, 2023
    Anticipated Study Completion Date :
    Feb 27, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. omics analysis [baseline]

      Measure of genomic, epigenetic and proteomic fingerprint of recruited patients

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS INM Neuromed, Department of Epidemiology and Prevention Pozzilli IS Italy 86077

    Sponsors and Collaborators

    • Neuromed IRCCS

    Investigators

    • Study Chair: licia Iacoviello, MD, PhD, IRCCS Neuromed

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Licia Iacoviello, Professor, Neuromed IRCCS
    ClinicalTrials.gov Identifier:
    NCT03279991
    Other Study ID Numbers:
    • 51/17
    First Posted:
    Sep 12, 2017
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Licia Iacoviello, Professor, Neuromed IRCCS
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2022