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Neuromed- Integrated Health Life Platform and Biobank (PLATONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279991
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Licia Iacoviello, 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.

Condition or disease
Cardiovascular Diseases Neuro-Degenerative Disease Cancer Pregnancy

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.

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Study Type : Observational
Estimated Enrollment : 120000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Neuromed- Integrated Health Life Platform and Biobank
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : February 27, 2022
Estimated Study Completion Date : February 27, 2022



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. omics analysis [ Time Frame: baseline ]
    Measure of genomic, epigenetic and proteomic fingerprint of recruited patients

  4. 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.


Biospecimen Retention:   Samples With DNA
The residual portion of biological withdrawals and materials normally used for the patient's therapeutic diagnostic route ( blood, urine, any fragments of biopsy tissue, surgical finds, umbilical cord, placenta sections, cephalorachidian fluid etc). In order to carry out any genetic-molecular investigations, DNA and DNA from these biological fluids and tissues will be extracted.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279991


Contacts
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Contact: Licia Iacoviello, MD, PhD +393485108779 licia.iacoviello@neuromed.it

Locations
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Italy
IRCCS INM Neuromed, Department of Epidemiology and Prevention Recruiting
Pozzilli, IS, Italy, 86077
Contact: Licia Iacoviello, MD, PhD       licia.iacoviello@neuromed.it   
Contact: Simona Esposito, BSC       simona.esposito@moli-sani.org   
Principal Investigator: Licia Iacoviello, Md, PhD         
Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Study Chair: licia Iacoviello, MD, PhD IRCCS Neuromed
Publications:
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Responsible Party: Licia Iacoviello, Professor, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03279991    
Other Study ID Numbers: 51/17
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Upon request
Access Criteria: Approval by the Moli-sani study Scientific committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Licia Iacoviello, Neuromed IRCCS:
biobank
chronic disease
omics
big data
4 P medicine
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Cardiovascular Diseases
Nervous System Diseases