<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/NCT02210299</url>
  </required_header>
  <id_info>
    <org_study_id>35RC13_8917_TEXTO</org_study_id>
    <secondary_id>2014-A00782-45</secondary_id>
    <secondary_id>14/25-941</secondary_id>
    <secondary_id>140682B-82</secondary_id>
    <nct_id>NCT02210299</nct_id>
  </id_info>
  <brief_title>TEXTO : Total EXposure To Organic Pollutants</brief_title>
  <acronym>TEXTO</acronym>
  <official_title>TEXTO : Total EXposure To Organic Pollutants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Recherche en Santé, Environnement et le Travail, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire d'Etude des Résidus et Contaminants dans les Aliments</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut national de l'environnement industriel et des risques</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Agency for Sanitary Safety of the Food of the Environment and Labor</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People are, especially in industrialized countries, exposed to a growing number of ubiquitous&#xD;
      chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and&#xD;
      dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought&#xD;
      to contribute the most to total exposure for many chemicals, the relative contribution of&#xD;
      each pathway is nevertheless poorly described, and can be different among populations. This&#xD;
      is in particularly the case For young children, who can be more exposed via the environment,&#xD;
      because of frequent contact with object and dust and hand to mouth behaviors. Children are in&#xD;
      addition considered more sensitive to chemical risk due to their maturating systems.&#xD;
&#xD;
      In this context, the objective of this project is to characterize the young children's&#xD;
      exposure to a particular class of semi volatile organic compounds. It will encompass the&#xD;
      relative contribution of different pathways to the external dose, and to try to match the&#xD;
      internal and external doses with a physiologically based pharmacokinetic (PBPK) model for&#xD;
      molecules for which it is possible.&#xD;
&#xD;
      The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated&#xD;
      Substances (PFAS), used in numerous consumer products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilot study for testing feasibility of cross sectional integrative exposure study.&#xD;
&#xD;
      Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of&#xD;
      internal (serum) and external doses (diet, indoor environment: contamination data and human&#xD;
      exposure factors; quantity ingested and breathed).&#xD;
&#xD;
      Expected outcomes :&#xD;
&#xD;
      Assessment of feasibility to obtain:&#xD;
&#xD;
        -  original data on children's body burden&#xD;
&#xD;
        -  original contamination data for food, water, air and dust ;&#xD;
&#xD;
        -  Matching of these data to identify main sources and pathways of exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility recruitment</measure>
    <time_frame>3 months</time_frame>
    <description>Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures.&#xD;
Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Protocol validation</measure>
    <time_frame>1 year</time_frame>
    <description>Second objective is to validate protocols, procedures and methods to study exposure to PFAS.&#xD;
Secondary judgment criteria :&#xD;
Possibility to sample an extra volume of blood, to prepare it and transport it at -18°C to Laberca lab, Nantes;&#xD;
Possibility to organize a home visit with sampling of diet, water, air, dust and delivery of dietary questionnaire;&#xD;
Possibility to quantify PFAS in dietary and environmental samples;&#xD;
Possibility to model the internal dose for some compounds from kinetics data, and to compare doses estimated from blood measurements to those from environmental and diet measurements</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Exposure study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>2-6 months-old children and 12-18 months-old children</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure study</intervention_name>
    <description>Sampling of blood, food, water, air and dust and delivery of dietary questionnaire</description>
    <arm_group_label>Exposure study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Young children (2-6 months ; 12-18 months)&#xD;
&#xD;
          -  In outpatient pediatric or pediatric surgery ;&#xD;
&#xD;
          -  From their homes ;&#xD;
&#xD;
          -  With home located less than 30km from Rennes ;&#xD;
&#xD;
          -  Living at their home (not at childcare facility or child-minder);&#xD;
&#xD;
          -  With a scheduled blood sampling apart from this study ;&#xD;
&#xD;
          -  For child 2 - 6 months :&#xD;
&#xD;
          -  With diet exclusively based on milk (maternal exclusively or commercial exclusively)&#xD;
&#xD;
          -  In case of breastfeeding, with mother accepting milk sampling ;&#xD;
&#xD;
          -  With a free, enlightened and signed written consent from the parents.&#xD;
&#xD;
        Breastfeeding mother :&#xD;
&#xD;
          -  &gt; 18 years ;&#xD;
&#xD;
          -  Exclusive breastfeeding ;&#xD;
&#xD;
          -  With a free, enlightened and signed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children :&#xD;
&#xD;
          -  Metabolic illness ;&#xD;
&#xD;
          -  Renal or hepatic insufficiency ;&#xD;
&#xD;
          -  Malabsorption&#xD;
&#xD;
          -  With known HIV+, HBV+, HCV+, CMV+ serology&#xD;
&#xD;
          -  Simultaneously participating to other biomedical survey&#xD;
&#xD;
        For breastfeeding mother :&#xD;
&#xD;
          -  Under legal protection (judicial protection, guardianship) ;&#xD;
&#xD;
          -  mixed breastfeeding ;&#xD;
&#xD;
          -  with Known HIV+, HBV+, HCV+, CMV+ serology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Glorennec, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Florence Rouget, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes Hospital University</name>
      <address>
        <city>Rennes</city>
        <state>Brittany</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy young children (2-6 months ; 12-18 months)</keyword>
  <!-- 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/NCT02210299
org study id: 35RC13_8917_TEXTO
secondary id: 2014-A00782-45
secondary id: 14/25-941
secondary id: 140682B-82
nct id: NCT02210299
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
People are, especially in industrialized countries, exposed to a growing number of ubiquitous
      chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and
      dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought
      to contribute the most to total exposure for many chemicals, the relative contribution of
      each pathway is nevertheless poorly described, and can be different among populations. This
      is in particularly the case For young children, who can be more exposed via the environment,
      because of frequent contact with object and dust and hand to mouth behaviors. Children are in
      addition considered more sensitive to chemical risk due to their maturating systems.

      In this context, the objective of this project is to characterize the young children's
      exposure to a particular class of semi volatile organic compounds. It will encompass the
      relative contribution of different pathways to the external dose, and to try to match the
      internal and external doses with a physiologically based pharmacokinetic (PBPK) model for
      molecules for which it is possible.

      The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated
      Substances (PFAS), used in numerous consumer products.
Pilot study for testing feasibility of cross sectional integrative exposure study.

      Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of
      internal (serum) and external doses (diet, indoor environment: contamination data and human
      exposure factors; quantity ingested and breathed).

      Expected outcomes :

      Assessment of feasibility to obtain:

        -  original data on children's body burden

        -  original contamination data for food, water, air and dust ;

        -  Matching of these data to identify main sources and pathways of exposure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Feasibility recruitment
time frame: 3 months
description: Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures.
Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.
measure: Protocol validation
time frame: 1 year
description: Second objective is to validate protocols, procedures and methods to study exposure to PFAS.
Secondary judgment criteria :
Possibility to sample an extra volume of blood, to prepare it and transport it at -18°C to Laberca lab, Nantes;
Possibility to organize a home visit with sampling of diet, water, air, dust and delivery of dietary questionnaire;
Possibility to quantify PFAS in dietary and environmental samples;
Possibility to model the internal dose for some compounds from kinetics data, and to compare doses estimated from blood measurements to those from environmental and diet measurements
arm group label: Exposure study
arm group type: Other
description: 2-6 months-old children and 12-18 months-old children
intervention type: Other
intervention name: Exposure study
description: Sampling of blood, food, water, air and dust and delivery of dietary questionnaire
arm group label: Exposure study
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Glorennec, PhD
role: Study Chair
affiliation: Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail
last name: Florence Rouget, MD
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor