Neuromed- Integrated Health Life Platform and Biobank (PLATONE)

November 11, 2023 updated by: Licia Iacoviello, Neuromed IRCCS
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • IS
      • Pozzilli, IS, Italy, 86077
        • IRCCS INM Neuromed, Department of Epidemiology and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted in the Neuromed group clinics who will have signed informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
omics analysis
Time Frame: baseline
Measure of genomic, epigenetic and proteomic fingerprint of recruited patients
baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.

IPD Sharing Time Frame

Upon request

IPD Sharing Access Criteria

Approval by the Moli-sani study Scientific committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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