<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03279991</url>
  </required_header>
  <id_info>
    <org_study_id>51/17</org_study_id>
    <nct_id>NCT03279991</nct_id>
  </id_info>
  <brief_title>Neuromed- Integrated Health Life Platform and Biobank</brief_title>
  <acronym>PLATONE</acronym>
  <official_title>Neuromed- Integrated Health Life Platform and Biobank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neuromed IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neuromed IRCCS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to create a digital platform for personal, clinical, diagnostic and&#xD;
      environmental data collection, management and analysis of patients with cardiovascular and&#xD;
      neurological disease or cancer admitted to the Neuromed Group clinics, associated with a&#xD;
      biobanks of biological fluids and human tissues and a biotechnological platform for &quot;omics&quot;&#xD;
      analysis, to encourage personalized, preventative and predictive care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a need for a change of vision in health care that could become a key innovation&#xD;
      point for digital medicine in the future, a sort of Copernican revolution: the starting point&#xD;
      is no longer the disease, but the patient around whom pathologies and risk factors rotate,&#xD;
      not as distinct and uniquely defined entities, but as communicating and interconnected&#xD;
      possibilities that define their form only in relation to the individual, his genome, his&#xD;
      personality, his habits of life and the environment in which he lives. From these&#xD;
      interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic&#xD;
      pathway is created that accompanies the person not only in the stage of the disease but also&#xD;
      in the previous and subsequent phases, becoming a way of life oriented towards the health of&#xD;
      the person rather than a way to cure a disease.&#xD;
&#xD;
      An Integrated Health Life Platform enables you to develop an interactive healthcare health&#xD;
      model among all actors who manage the health of the person, healthcare professionals in the&#xD;
      area, and hospitals, caregivers, and community through the integration of remote monitoring&#xD;
      of data with A virtual community.&#xD;
&#xD;
      The platform is thought not as a pure aggregation of data, but as a digital hub centered on&#xD;
      the patient, with his (clinical and personal) data, but also the environment in which he&#xD;
      lives, his behaviors, accessibility to services and The relationships that come to them and&#xD;
      from them. The platform aims to effectively integrate self management, personalization of the&#xD;
      path, and co-production of health, demonstrating that these three key dimensions of care are&#xD;
      mutually reinforcing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">February 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biological sample bank</measure>
    <time_frame>baseline</time_frame>
    <description>A repository of biological samples, &quot;Neurobiobank&quot;, 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Integrated health-life big data platform</measure>
    <time_frame>baseline</time_frame>
    <description>Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>omics analysis</measure>
    <time_frame>baseline</time_frame>
    <description>Measure of genomic, epigenetic and proteomic fingerprint of recruited patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Four P (4P) medicine</measure>
    <time_frame>Baseline</time_frame>
    <description>Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.</description>
  </primary_outcome>
  <enrollment type="Anticipated">120000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Neuro-Degenerative Disease</condition>
  <condition>Cancer</condition>
  <condition>Pregnancy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The residual portion of biological withdrawals and materials normally used for the patient's&#xD;
      therapeutic diagnostic route ( blood, urine, any fragments of biopsy tissue, surgical finds,&#xD;
      umbilical cord, placenta sections, cephalorachidian fluid etc). In order to carry out any&#xD;
      genetic-molecular investigations, DNA and DNA from these biological fluids and tissues will&#xD;
      be extracted.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted in the Neuromed group clinics who will have signed informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  neurodegenerative disease&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand and to want&#xD;
&#xD;
          -  Refusal to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>licia Iacoviello, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS Neuromed</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Licia Iacoviello, MD, PhD</last_name>
    <phone>+393485108779</phone>
    <email>licia.iacoviello@neuromed.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>IRCCS INM Neuromed, Department of Epidemiology and Prevention</name>
      <address>
        <city>Pozzilli</city>
        <state>IS</state>
        <zip>86077</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Licia Iacoviello, MD, PhD</last_name>
      <email>licia.iacoviello@neuromed.it</email>
    </contact>
    <contact_backup>
      <last_name>Simona Esposito, BSC</last_name>
      <email>simona.esposito@moli-sani.org</email>
    </contact_backup>
    <investigator>
      <last_name>Licia Iacoviello, Md, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>27665228</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24762252</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21749975</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28518059</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27521224</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Neuromed IRCCS</investigator_affiliation>
    <investigator_full_name>Licia Iacoviello</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>biobank</keyword>
  <keyword>chronic disease</keyword>
  <keyword>omics</keyword>
  <keyword>big data</keyword>
  <keyword>4 P medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodegenerative Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Upon request</ipd_time_frame>
    <ipd_access_criteria>Approval by the Moli-sani study Scientific committee</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03279991
org study id: 51/17
nct id: NCT03279991
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Biological sample bank
time frame: baseline
description: 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.
measure: Integrated health-life big data platform
time frame: baseline
description: Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.
measure: omics analysis
time frame: baseline
description: Measure of genomic, epigenetic and proteomic fingerprint of recruited patients
measure: Four P (4P) medicine
time frame: Baseline
description: Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: licia Iacoviello, MD, PhD
role: Study Chair
affiliation: IRCCS Neuromed
last name: Licia Iacoviello, MD, PhD
phone: +393485108779
email: licia.iacoviello@neuromed.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
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.
PMID: 27665228
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.
PMID: 24762252
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.
PMID: 21749975
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.
PMID: 28518059
citation: 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.
PMID: 27521224
responsible party type: Principal Investigator
investigator affiliation: Neuromed IRCCS
investigator full name: Licia Iacoviello
investigator title: Professor
mesh term: Neurodegenerative Diseases
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Upon request
ipd access criteria: Approval by the Moli-sani study Scientific committee