<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/NCT02986763</url>
  </required_header>
  <id_info>
    <org_study_id>SIGEXPOSOME</org_study_id>
    <nct_id>NCT02986763</nct_id>
  </id_info>
  <brief_title>Evaluation of Pesticide Exposure in the General Population</brief_title>
  <acronym>SIGEXPOSOME</acronym>
  <official_title>Evaluation of Pesticide Exposure in the General Population: Use of Spatial, Environmental, Toxicological and Biological Approaches</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Leon Berard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancéropôle Lyon Auvergne Rhône-Alpes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Agency for Research on Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rovaltain Research Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de rechercher en Cancérologie de Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Leon Berard</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An association has been suggested with several diseases including cancer and IARC has&#xD;
      classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a&#xD;
      better characterisation of environmental pesticides exposures and identification of suitable&#xD;
      biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure&#xD;
      on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen&#xD;
      epidemiological hypotheses on the association with several cancer types.&#xD;
&#xD;
      The main objective of the project is to validate a GIS (geographic information system) based&#xD;
      method to assess environmental pesticide exposures, using environmental (contamination of&#xD;
      housedust) and biological (blood and urine samples) measures. The project aims further to&#xD;
      investigate a potential link between housedust contamination and biological measures in&#xD;
      healthy non-smoking male residents and explore the impact of environmental pesticide exposure&#xD;
      on metabolomics, transcriptomic and epigenetic parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project involves a pilot phase involving repeated (twice) sampling in 20 male non-smoking&#xD;
      volunteers living in the Beaujolais region (France) to perform appropriate calibrations for&#xD;
      metabolomic, transcriptomic and epigenetic analyses. The main study will be conducted in a&#xD;
      sample of 150 male non-smoking volunteers and 50 professional pesticides applicators from the&#xD;
      same region (3 sampling periods).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>level of pesticide exposures</measure>
    <time_frame>up to 2 years</time_frame>
    <description>environmental, occupational and domestic exposures</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">166</enrollment>
  <condition>Pesticide Poisoning</condition>
  <arm_group>
    <arm_group_label>Professional pesticides</arm_group_label>
    <description>A specific questionnaire with professional information about pesticide uses is added for this arm Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteers</arm_group_label>
    <description>Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Questionnaire, blood, urine, hair and dust samplings</intervention_name>
    <arm_group_label>Professional pesticides</arm_group_label>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers living in the Beaujolais region (France)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non smokers in the last two years Living in the Beaujolais region (France) within&#xD;
             1000m of vignards Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers sharing the same households with professional applicators of pesticides&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
  </condition_browse>
  <!-- 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/NCT02986763
org study id: SIGEXPOSOME
nct id: NCT02986763
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
An association has been suggested with several diseases including cancer and IARC has
      classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a
      better characterisation of environmental pesticides exposures and identification of suitable
      biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure
      on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen
      epidemiological hypotheses on the association with several cancer types.

      The main objective of the project is to validate a GIS (geographic information system) based
      method to assess environmental pesticide exposures, using environmental (contamination of
      housedust) and biological (blood and urine samples) measures. The project aims further to
      investigate a potential link between housedust contamination and biological measures in
      healthy non-smoking male residents and explore the impact of environmental pesticide exposure
      on metabolomics, transcriptomic and epigenetic parameters.
The project involves a pilot phase involving repeated (twice) sampling in 20 male non-smoking
      volunteers living in the Beaujolais region (France) to perform appropriate calibrations for
      metabolomic, transcriptomic and epigenetic analyses. The main study will be conducted in a
      sample of 150 male non-smoking volunteers and 50 professional pesticides applicators from the
      same region (3 sampling periods).
observational model: Cohort
time perspective: Cross-Sectional
measure: level of pesticide exposures
time frame: up to 2 years
description: environmental, occupational and domestic exposures
arm group label: Professional pesticides
description: A specific questionnaire with professional information about pesticide uses is added for this arm Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling
arm group label: Volunteers
description: Questionnaire to collect domestic pesticide use, diet, household characteristics Dust sampling Blood sampling Urine sampling Hair sampling
intervention type: Biological
intervention name: Questionnaire, blood, urine, hair and dust samplings
arm group label: Professional pesticides
arm group label: Volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Poisoning