<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/NCT03788187</url>
  </required_header>
  <id_info>
    <org_study_id>2013-A00663-42</org_study_id>
    <nct_id>NCT03788187</nct_id>
  </id_info>
  <brief_title>Persistant Organics Pollutants in Breast Cancer.</brief_title>
  <acronym>METAPOP</acronym>
  <official_title>Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Georges Pompidou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ONIRIS</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>European Georges Pompidou Hospital</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>
      Persistant Organics Pollutants (POP) accumulate in the adipose tissue (AT) and could modulate&#xD;
      tumor progression as part of the microenvironment. The investigators tested the hypothesis&#xD;
      that POPs exposure may be associated with breast cancer metastasis analyzing the&#xD;
      concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients&#xD;
      (benign, malignant with and without lymph node metastasis)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators set up a longitudinal prospective monocentric cohort study in the&#xD;
      gynecologic-oncologic surgery department of European Hospital Georges-Pompidou, with patients&#xD;
      undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal&#xD;
      and sampling of the adipocytic tumour microenvironment to measure POPs using gas&#xD;
      chromatography coupled to high-resolution mass spectrometry. The objective is to analyze the&#xD;
      concentrations of 46 POPs including polychlorinated dibenzo(p)dioxins and furans (PCDD/Fs),&#xD;
      polychlorinated biphenyls (PCBs), polybromodiphenyl ethers (PBDEs) and polybromobiphenyls&#xD;
      (PBBs) in both adipose tissue (AT) and serum samples from breast tumor patients (benign,&#xD;
      malignant with and without lymph node metastasis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 27, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Analyzing the concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Metastatic lymph node status based of persistant organic pollutants level measured by by gas chromatography coupled to high-resolution mass spectrometry.</measure>
    <time_frame>Sampling the day of surgery</time_frame>
    <description>Correlation between 1) the concentrations of 46 persistant organic pollutants (including polychlorinated dibenzo(p)dioxin and furan, PCBs, polybromodiphenyl ethers and polybromobiphenyls measured by by gas chromatography coupled to high-resolution mass spectrometry on double sector instruments (JEOL MS 700D and 800D) after electron impact ionization (70 eV), operating at 10000 resolutions (10% valley) and in the single ion monitoring (SIM) acquisition mode) in both adipose tissue and serum samples and 2) breast cancer status (with and without lymph node metastasis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation between the mRNA levels of metastatic biomarkers measured by quantitative reverse transcriptase polymerase chain reaction amplification (PCR) in tumors (based of metastatic lymph node status) and the levels of persistant organic pollutants measured by gas chromatography coupled to high-resolution mass spectrometry.&#xD;
List of genes measured : Epithelial-to-mesenchymal (ECadherin, SNAIL, SLUG), matrix metalloproteases, metabolism, vascular endothelial grown factor, stem-cell properties, hormon receptor, inflammatory genes, xenobiotic receptor Aryl Hydrocarbon receptor (AhR).</description>
  </secondary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Persistant Organic Pollutants</condition>
  <condition>Lymph Node Metastases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test sample</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peritumoral adipose tissue sample</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with breast tumor: benign or malignant&#xD;
&#xD;
          -  Tumor size at least 1cm or palpable tumor&#xD;
&#xD;
          -  Undergoing a breast surgery in European Georges Pompidou hospital&#xD;
&#xD;
          -  Understanding the protocol and who signed a written consent&#xD;
&#xD;
        Exclusion Criteria: patients unable to give informed consent&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne-Sophie BATS, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European Hospital Georges Pompidou</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>European Georges Pompidou Hospital</investigator_affiliation>
    <investigator_full_name>Koual Meriem</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</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/NCT03788187
org study id: 2013-A00663-42
nct id: NCT03788187
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Persistant Organics Pollutants (POP) accumulate in the adipose tissue (AT) and could modulate
      tumor progression as part of the microenvironment. The investigators tested the hypothesis
      that POPs exposure may be associated with breast cancer metastasis analyzing the
      concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients
      (benign, malignant with and without lymph node metastasis)
The investigators set up a longitudinal prospective monocentric cohort study in the
      gynecologic-oncologic surgery department of European Hospital Georges-Pompidou, with patients
      undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal
      and sampling of the adipocytic tumour microenvironment to measure POPs using gas
      chromatography coupled to high-resolution mass spectrometry. The objective is to analyze the
      concentrations of 46 POPs including polychlorinated dibenzo(p)dioxins and furans (PCDD/Fs),
      polychlorinated biphenyls (PCBs), polybromodiphenyl ethers (PBDEs) and polybromobiphenyls
      (PBBs) in both adipose tissue (AT) and serum samples from breast tumor patients (benign,
      malignant with and without lymph node metastasis).
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: Analyzing the concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).
measure: Metastatic lymph node status based of persistant organic pollutants level measured by by gas chromatography coupled to high-resolution mass spectrometry.
time frame: Sampling the day of surgery
description: Correlation between 1) the concentrations of 46 persistant organic pollutants (including polychlorinated dibenzo(p)dioxin and furan, PCBs, polybromodiphenyl ethers and polybromobiphenyls measured by by gas chromatography coupled to high-resolution mass spectrometry on double sector instruments (JEOL MS 700D and 800D) after electron impact ionization (70 eV), operating at 10000 resolutions (10% valley) and in the single ion monitoring (SIM) acquisition mode) in both adipose tissue and serum samples and 2) breast cancer status (with and without lymph node metastasis)
measure: Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.
time frame: 2 years
description: Correlation between the mRNA levels of metastatic biomarkers measured by quantitative reverse transcriptase polymerase chain reaction amplification (PCR) in tumors (based of metastatic lymph node status) and the levels of persistant organic pollutants measured by gas chromatography coupled to high-resolution mass spectrometry.
List of genes measured : Epithelial-to-mesenchymal (ECadherin, SNAIL, SLUG), matrix metalloproteases, metabolism, vascular endothelial grown factor, stem-cell properties, hormon receptor, inflammatory genes, xenobiotic receptor Aryl Hydrocarbon receptor (AhR).
intervention type: Other
intervention name: Blood test sample
intervention type: Other
intervention name: Peritumoral adipose tissue sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Sophie BATS, MD, PhD
role: Principal Investigator
affiliation: European Hospital Georges Pompidou
responsible party type: Principal Investigator
investigator affiliation: European Georges Pompidou Hospital
investigator full name: Koual Meriem
investigator title: Associate professor
mesh term: Breast Neoplasms
mesh term: Lymphatic Metastasis