<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/NCT03242109</url>
  </required_header>
  <id_info>
    <org_study_id>50/17</org_study_id>
    <nct_id>NCT03242109</nct_id>
  </id_info>
  <brief_title>The Moli-sani Study</brief_title>
  <official_title>An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region</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>Yes</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>
      Cardiovascular disease and malignancies account for more than 70% of all causes of mortality&#xD;
      and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle,&#xD;
      that often defines the line between health and sickness. So far studies aiming at identifying&#xD;
      risk factors have mainly come from Northern Europe and the USA. It was to understand this&#xD;
      balance between genetics and environmental determinants better, and to tailor appropriate&#xD;
      preventive strategies for Italian and other Southern European populations, that the Moli-sani&#xD;
      study was launched, transforming a small Italian region into a large scientific laboratory:&#xD;
      the &quot;Molise lab&quot;.&#xD;
&#xD;
      Each participant received a thorough medical check-up at no cost to either him/her or the&#xD;
      national health service, resulting in thousands of hours of free public health care. With a&#xD;
      completely computerized system, Moli-sani is a &quot;paperless&quot; study, in which researchers and&#xD;
      participants communicate using recently developed technologies such as mobile phone text&#xD;
      messages (SMS). The biological data bank (the &quot;MoliBank&quot;) is one of the largest in Europe.&#xD;
      Paying particular attention towards innovation and new technologies, the Moli-sani study has&#xD;
      placed itself at the cutting edge of a new paradigm crossing research and prevention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cohort of the Moli-sani study has recruited 24,325 persons, aged &gt;35 years, resident in&#xD;
      the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants&#xD;
      are recruited from city-hall registries by a multistage sampling. Firstly townships were&#xD;
      sampled in three major areas of Molise region, starting from the main cities (Campobasso,&#xD;
      Termoli, Isernia) by cluster sampling, then, within each township, participants are selected&#xD;
      by simple random sampling, using electronically generated numbers.Exclusion criteria are&#xD;
      pregnancy at the time of recruitment, disturbances in understanding or willingness, current&#xD;
      poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are&#xD;
      sent a letter inviting them to participate in the project, followed a few days later by a&#xD;
      phone call. The recruitment started in the area of Campobasso, then it moved to the areas of&#xD;
      Termoli.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2005</start_date>
  <completion_date type="Actual">April 30, 2010</completion_date>
  <primary_completion_date type="Actual">April 30, 2010</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary cardiovascular diseases</measure>
    <time_frame>10 years</time_frame>
    <description>Primary fatal and nonfatal incident cases of CHD (unstable angina, myocardial infarction, coronary revascularization and sudden death for unspecified cardiac event) and cerebrovascular disease that occurred in the cohort during follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer</measure>
    <time_frame>10 years</time_frame>
    <description>Primary fatal and nonfatal incident cases of cancer that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart failure</measure>
    <time_frame>10 years</time_frame>
    <description>Primary fatal and nonfatal incident cases of heart failure that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>10 years</time_frame>
    <description>Primary fatal and nonfatal incident cases of atrial fibrillation that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes</measure>
    <time_frame>10 years</time_frame>
    <description>Primary incident cases of diabetes that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry or pharmacological prescription registry. Diabetes onset is defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment</description>
  </primary_outcome>
  <enrollment type="Actual">24325</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Cancer</condition>
  <condition>Neurodegenerative Diseases</condition>
  <condition>Diabetes</condition>
  <condition>Pulmonary Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples obtained from participants who had fasted overnight and had refrained from&#xD;
      smoking for at least 6 h and stored in liquid nitrogen in the Biological bank of the&#xD;
      Moli-sani study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Moli-sani is a population-based cohort study that recruited, between March 2005 and April&#xD;
        2010, 24,325 men and women at random from individuals aged 35 years or older resident in&#xD;
        the Molise region, to investigate genetic and environmental risk factors for&#xD;
        cardiovascular, cerebrovascular and tumour diseases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident in the Molise region (Italy), aged &gt;35.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy at the time of recruitment, disturbances in understanding or willingness,&#xD;
             current poly-traumas or coma, refusal to sign the Informed Consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Licia Iacoviello, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Epidemiology and Prevention, IRCCS Neuromed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Irccs Neuromed</name>
      <address>
        <city>Pozzilli</city>
        <zip>86067</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Pounis G, Tabolacci C, Costanzo S, Cordella M, Bonaccio M, Rago L, D'Arcangelo D, Filippo Di Castelnuovo A, de Gaetano G, Donati MB, Iacoviello L, Facchiano F; Moli-sani study investigators. Reduction by coffee consumption of prostate cancer risk: Evidence from the Moli-sani cohort and cellular models. Int J Cancer. 2017 Jul 1;141(1):72-82. doi: 10.1002/ijc.30720. Epub 2017 Apr 24.</citation>
    <PMID>28436066</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonaccio M, Di Castelnuovo A, Costanzo S, de Curtis A, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI study Investigators. Mean platelet volume is associated with lower risk of overall and non-vascular mortality in a general population. Results from the Moli-sani study. Thromb Haemost. 2017 Jun 2;117(6):1129-1140. doi: 10.1160/TH16-12-0974. Epub 2017 Mar 30.</citation>
    <PMID>28357442</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</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>MD, PhD</investigator_title>
  </responsible_party>
  <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>sumbmission 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/NCT03242109
org study id: 50/17
nct id: NCT03242109
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease and malignancies account for more than 70% of all causes of mortality
      and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle,
      that often defines the line between health and sickness. So far studies aiming at identifying
      risk factors have mainly come from Northern Europe and the USA. It was to understand this
      balance between genetics and environmental determinants better, and to tailor appropriate
      preventive strategies for Italian and other Southern European populations, that the Moli-sani
      study was launched, transforming a small Italian region into a large scientific laboratory:
      the "Molise lab".

      Each participant received a thorough medical check-up at no cost to either him/her or the
      national health service, resulting in thousands of hours of free public health care. With a
      completely computerized system, Moli-sani is a "paperless" study, in which researchers and
      participants communicate using recently developed technologies such as mobile phone text
      messages (SMS). The biological data bank (the "MoliBank") is one of the largest in Europe.
      Paying particular attention towards innovation and new technologies, the Moli-sani study has
      placed itself at the cutting edge of a new paradigm crossing research and prevention
The cohort of the Moli-sani study has recruited 24,325 persons, aged >35 years, resident in
      the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants
      are recruited from city-hall registries by a multistage sampling. Firstly townships were
      sampled in three major areas of Molise region, starting from the main cities (Campobasso,
      Termoli, Isernia) by cluster sampling, then, within each township, participants are selected
      by simple random sampling, using electronically generated numbers.Exclusion criteria are
      pregnancy at the time of recruitment, disturbances in understanding or willingness, current
      poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are
      sent a letter inviting them to participate in the project, followed a few days later by a
      phone call. The recruitment started in the area of Campobasso, then it moved to the areas of
      Termoli.
observational model: Cohort
time perspective: Prospective
measure: Primary cardiovascular diseases
time frame: 10 years
description: Primary fatal and nonfatal incident cases of CHD (unstable angina, myocardial infarction, coronary revascularization and sudden death for unspecified cardiac event) and cerebrovascular disease that occurred in the cohort during follow-up
measure: Cancer
time frame: 10 years
description: Primary fatal and nonfatal incident cases of cancer that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry
measure: Heart failure
time frame: 10 years
description: Primary fatal and nonfatal incident cases of heart failure that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry
measure: Atrial fibrillation
time frame: 10 years
description: Primary fatal and nonfatal incident cases of atrial fibrillation that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry
measure: Diabetes
time frame: 10 years
description: Primary incident cases of diabetes that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry or pharmacological prescription registry. Diabetes onset is defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment
Blood samples obtained from participants who had fasted overnight and had refrained from
      smoking for at least 6 h and stored in liquid nitrogen in the Biological bank of the
      Moli-sani study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
last name: Licia Iacoviello, MD, PhD
role: Principal Investigator
affiliation: Department of Epidemiology and Prevention, IRCCS Neuromed
facility: 
country: Italy
citation: Pounis G, Tabolacci C, Costanzo S, Cordella M, Bonaccio M, Rago L, D'Arcangelo D, Filippo Di Castelnuovo A, de Gaetano G, Donati MB, Iacoviello L, Facchiano F; Moli-sani study investigators. Reduction by coffee consumption of prostate cancer risk: Evidence from the Moli-sani cohort and cellular models. Int J Cancer. 2017 Jul 1;141(1):72-82. doi: 10.1002/ijc.30720. Epub 2017 Apr 24.
PMID: 28436066
citation: Bonaccio M, Di Castelnuovo A, Costanzo S, de Curtis A, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI study Investigators. Mean platelet volume is associated with lower risk of overall and non-vascular mortality in a general population. Results from the Moli-sani study. Thromb Haemost. 2017 Jun 2;117(6):1129-1140. doi: 10.1160/TH16-12-0974. Epub 2017 Mar 30.
PMID: 28357442
responsible party type: Principal Investigator
investigator affiliation: Neuromed IRCCS
investigator full name: Licia Iacoviello
investigator title: MD, PhD
mesh term: Neurodegenerative Diseases
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: sumbmission 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