xml: <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/NCT05976126</url>
    </required_header>
    <id_info>
      <org_study_id>59</org_study_id>
      <nct_id>NCT05976126</nct_id>
    </id_info>
    <brief_title>Characterization of a Population Living in Highly Contaminated Settlement in Campania Region</brief_title>
    <acronym>SPES</acronym>
    <official_title>Characterization of a Population Living in Highly Contaminated Settlement in Campania Region</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Francesca De Filippis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federico II University</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>
        some areas in the Campania region (southern Italy) have attracted media coverage in the past&#xD;
        15 years, and are considered a dramatic example of an extremely polluted area. The&#xD;
        environmental pollution issue has become a significant concern in the Campania Region as a&#xD;
        result of the &quot;waste management crisis&quot; that mainly affects the northern part of the region,&#xD;
        encompassing 91 municipalities. As a consequence, in the last few decades, a large rural area&#xD;
        between the provinces of Naples and Caserta, primarily used for agriculture and livestock&#xD;
        breeding, was considered to be at high risk of contamination due to the illegal disposal of&#xD;
        urban and industrial waste. In these landfills, a broad range of hazardous wastes from&#xD;
        different parts of Italy has been found. In addition, the wastes have often been open-air&#xD;
        burned, leading to this area being named the &quot;Land of Fires&quot;. Senior and Mazza first&#xD;
        highlighted the high incidence of cancer deaths in a specific area of the Campania region&#xD;
        (compared to regional and national rates), which was identified by the authors as the&#xD;
        &quot;triangle of death&quot;. Afterwards, several studies reported a link between illegal waste&#xD;
        disposal and an increased risk of cancer for the population, potentially associated with&#xD;
        human exposure to carcinogenic substances such as dioxins, dioxin-like compounds, or&#xD;
        polycyclic aromatic hydrocarbons, which can be released into air, soil, and water bodies&#xD;
        through the illegal dumping and burning of waste. Within this study, 4,227 subjects were&#xD;
        enrolled in the SPES trial, considering healthy subjects living in several regional areas&#xD;
        with different environmental pressures. Blood dioxins and heavy metals were analyzed. Gut&#xD;
        microbiome was analyzed on a subset of 359 subjects from the three different exposure area.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study involved a screening of healthy adults from Campania region recruited in the human&#xD;
        biomonitoring study SPES (http://spes.campaniatrasparente.it), promoted by the Istituto&#xD;
        Zooprofilattico Sperimentale del Mezzogiorno (IZSM) of Portici (Italy) in collaboration with&#xD;
        the National Tumor Institute IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) &quot;G.&#xD;
        Pascale&quot; in Naples. Considering different source of environmental pressure (e.g., land use&#xD;
        and population density, presence of contaminated sites, quality of air, soil and water&#xD;
        bodies, closeness to waste management plants and illegal waste spills and fires), Pizzolante&#xD;
        and colleagues developed an integrated model to compute the Municipality Index of&#xD;
        Environmental Pressure (MIEP). The MIEP takes into account all factors involved in the&#xD;
        pollution processes, including the sources of contaminants and their migration pathways. The&#xD;
        MIEP enables the identification of 21 homogeneous sub-clusters, which include several&#xD;
        municipalities based on their environmental pressure scores. This categorization has resulted&#xD;
        in three macro-areas with increasing levels of impact pressure: LOW, MEDIUM and HIGH, as&#xD;
        described by Pierri and colleagues. In 2016, a total of 4,227 subjects were enrolled in the&#xD;
        SPES trial, considering healthy subjects living in several regional areas with different&#xD;
        environmental pressures. A subgroup of 359 subjects residing in the three impact areas was&#xD;
        randomly selected from the entire SPES cohort for gut microbiome analysis, in order to define&#xD;
        the impact of environmental pollution on gut microbial communities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 10, 2016</start_date>
    <completion_date type="Actual">August 3, 2017</completion_date>
    <primary_completion_date type="Actual">August 3, 2017</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of plasmatic concentration of dioxins (PCDD/Fs) and polychlorinated biphenyls (PCBs) in subjects from high, medium and low pollution area as assessed by HRGC-HRMS</measure>
      <time_frame>at enrollement</time_frame>
      <description>measure of PCDD/Fs and PCBs in human blood serum using High-Resolution Gas Chromathography coupled to High-Resolution Mass Spectrometry (HRGC-HRMS) analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of plasmatic concentration of trace elements in subjects from high, medium and low pollution area as assessed by ICP-MS</measure>
      <time_frame>at enrollement</time_frame>
      <description>trace elements (arsenic, beryllium, cadmium, cobalt, chromium, copper, iron, mercury, lithium, manganese, molybdenum, nickel, lead, antimony, selenium, strontium, thallium, vanadium, and zinc) were determined in human plasma using an inductively coupled plasma mass spectrometer (ICP-MS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of gut microbiome composition and functions in subjects from high, medium and low pollution area as assessed by metagenomics</measure>
      <time_frame>at enrollement</time_frame>
      <description>Microbiome composition and potential functions was determined by shotgun metagenomics (Illumina paired-end sequencing, 2x150bp). The massive amount of sequences obtained was analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species and genes occurring in each sample was determined.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">4227</enrollment>
    <condition>Environmental-Pollution-Related Condition</condition>
    <arm_group>
      <arm_group_label>High environmental pollution group (HIGH)</arm_group_label>
      <description>subjects living in area characterized by high environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medium environmental pollution group (MEDIUM)</arm_group_label>
      <description>subjects living in area characterized by medium environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low environmental pollution group (LOW)</arm_group_label>
      <description>subjects living in area characterized by low environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements</intervention_name>
      <description>Peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the early morning, in blood collection tubes (SST II Advance Tubes, BD Vacutainer). The samples were left for approximately 50 min, then the serum was separated from whole blood by centrifugation at 2,000 rcf for 10 min at 4 °C and then aliquots were stored at -80°C until analysis.</description>
      <arm_group_label>High environmental pollution group (HIGH)</arm_group_label>
      <arm_group_label>Low environmental pollution group (LOW)</arm_group_label>
      <arm_group_label>Medium environmental pollution group (MEDIUM)</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Fecal samples were self-collected and frozen at -80°C for microbial DNA extraction;&#xD;
        peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the&#xD;
        early morning, in blood collection tubes&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults (20-50 years/old) resident in one of the municipalities under study for at&#xD;
          least 5 years (Campania Region, Italy) grouped according to the environmental impact (high,&#xD;
          medium and low) (as reported in http://www.campaniatrasparente.it)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  healthy subjects (no severe, chronic or neoplastic conditions)&#xD;
  &#xD;
            -  20-50 years old&#xD;
  &#xD;
            -  both sexes&#xD;
  &#xD;
            -  no important viral infection (HIV, HCV, HBV)&#xD;
  &#xD;
            -  no use of drugs&#xD;
  &#xD;
            -  no alcohol abuse&#xD;
  &#xD;
            -  no obesity of II, III and IV classes.&#xD;
  &#xD;
            -  resident in one of the municipalities under study for at least 5 years (Campania&#xD;
               Region, Italy)&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  age &lt; 20 and &gt; 50 years at enrollment&#xD;
  &#xD;
            -  severe, chronic or neoplastic conditions&#xD;
  &#xD;
            -  viral infections (HIV, HCV, HBV)&#xD;
  &#xD;
            -  use of drugs or alcohol&#xD;
  &#xD;
            -  obesity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Federico II University</investigator_affiliation>
      <investigator_full_name>Francesca De Filippis</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>dioxins</keyword>
    <keyword>persistent organic pollutants</keyword>
    <keyword>heavy metals</keyword>
    <keyword>gut microbiome</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trace Elements</mesh_term>
      <mesh_term>Micronutrients</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976126
  org study id: 59
  nct id: NCT05976126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  some areas in the Campania region (southern Italy) have attracted media coverage in the past
        15 years, and are considered a dramatic example of an extremely polluted area. The
        environmental pollution issue has become a significant concern in the Campania Region as a
        result of the "waste management crisis" that mainly affects the northern part of the region,
        encompassing 91 municipalities. As a consequence, in the last few decades, a large rural area
        between the provinces of Naples and Caserta, primarily used for agriculture and livestock
        breeding, was considered to be at high risk of contamination due to the illegal disposal of
        urban and industrial waste. In these landfills, a broad range of hazardous wastes from
        different parts of Italy has been found. In addition, the wastes have often been open-air
        burned, leading to this area being named the "Land of Fires". Senior and Mazza first
        highlighted the high incidence of cancer deaths in a specific area of the Campania region
        (compared to regional and national rates), which was identified by the authors as the
        "triangle of death". Afterwards, several studies reported a link between illegal waste
        disposal and an increased risk of cancer for the population, potentially associated with
        human exposure to carcinogenic substances such as dioxins, dioxin-like compounds, or
        polycyclic aromatic hydrocarbons, which can be released into air, soil, and water bodies
        through the illegal dumping and burning of waste. Within this study, 4,227 subjects were
        enrolled in the SPES trial, considering healthy subjects living in several regional areas
        with different environmental pressures. Blood dioxins and heavy metals were analyzed. Gut
        microbiome was analyzed on a subset of 359 subjects from the three different exposure area.
  This study involved a screening of healthy adults from Campania region recruited in the human
        biomonitoring study SPES (http://spes.campaniatrasparente.it), promoted by the Istituto
        Zooprofilattico Sperimentale del Mezzogiorno (IZSM) of Portici (Italy) in collaboration with
        the National Tumor Institute IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) "G.
        Pascale" in Naples. Considering different source of environmental pressure (e.g., land use
        and population density, presence of contaminated sites, quality of air, soil and water
        bodies, closeness to waste management plants and illegal waste spills and fires), Pizzolante
        and colleagues developed an integrated model to compute the Municipality Index of
        Environmental Pressure (MIEP). The MIEP takes into account all factors involved in the
        pollution processes, including the sources of contaminants and their migration pathways. The
        MIEP enables the identification of 21 homogeneous sub-clusters, which include several
        municipalities based on their environmental pressure scores. This categorization has resulted
        in three macro-areas with increasing levels of impact pressure: LOW, MEDIUM and HIGH, as
        described by Pierri and colleagues. In 2016, a total of 4,227 subjects were enrolled in the
        SPES trial, considering healthy subjects living in several regional areas with different
        environmental pressures. A subgroup of 359 subjects residing in the three impact areas was
        randomly selected from the entire SPES cohort for gut microbiome analysis, in order to define
        the impact of environmental pollution on gut microbial communities.
  observational model: Cohort
  time perspective: Retrospective
  measure: Comparison of plasmatic concentration of dioxins (PCDD/Fs) and polychlorinated biphenyls (PCBs) in subjects from high, medium and low pollution area as assessed by HRGC-HRMS
  time frame: at enrollement
  description: measure of PCDD/Fs and PCBs in human blood serum using High-Resolution Gas Chromathography coupled to High-Resolution Mass Spectrometry (HRGC-HRMS) analysis
  measure: Comparison of plasmatic concentration of trace elements in subjects from high, medium and low pollution area as assessed by ICP-MS
  time frame: at enrollement
  description: trace elements (arsenic, beryllium, cadmium, cobalt, chromium, copper, iron, mercury, lithium, manganese, molybdenum, nickel, lead, antimony, selenium, strontium, thallium, vanadium, and zinc) were determined in human plasma using an inductively coupled plasma mass spectrometer (ICP-MS)
  measure: Comparison of gut microbiome composition and functions in subjects from high, medium and low pollution area as assessed by metagenomics
  time frame: at enrollement
  description: Microbiome composition and potential functions was determined by shotgun metagenomics (Illumina paired-end sequencing, 2x150bp). The massive amount of sequences obtained was analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species and genes occurring in each sample was determined.
  arm group label: High environmental pollution group (HIGH)
  description: subjects living in area characterized by high environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]
  arm group label: Medium environmental pollution group (MEDIUM)
  description: subjects living in area characterized by medium environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]
  arm group label: Low environmental pollution group (LOW)
  description: subjects living in area characterized by low environmental pollution, as defined by Pizzolante et al. [Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).]
  intervention type: Other
  intervention name: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements
  description: Peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the early morning, in blood collection tubes (SST II Advance Tubes, BD Vacutainer). The samples were left for approximately 50 min, then the serum was separated from whole blood by centrifugation at 2,000 rcf for 10 min at 4 °C and then aliquots were stored at -80°C until analysis.
  arm group label: High environmental pollution group (HIGH)
  arm group label: Low environmental pollution group (LOW)
  arm group label: Medium environmental pollution group (MEDIUM)
  Fecal samples were self-collected and frozen at -80°C for microbial DNA extraction;
        peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the
        early morning, in blood collection tubes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor-Investigator
  investigator affiliation: Federico II University
  investigator full name: Francesca De Filippis
  investigator title: Professor
  mesh term: Trace Elements
  mesh term: Micronutrients
  sharing ipd: Undecided