<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/NCT04429490</url>
  </required_header>
  <id_info>
    <org_study_id>PA20035</org_study_id>
    <nct_id>NCT04429490</nct_id>
  </id_info>
  <brief_title>Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma</brief_title>
  <acronym>PESTIPAC</acronym>
  <official_title>Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new&#xD;
      cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in&#xD;
      Grand Est region. National incidence has doubled for men and tripled for women between 1982&#xD;
      and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all&#xD;
      stages 5-year survival. It will become the second deadliest in Europe, behind&#xD;
      bronchopulmonary cancer.&#xD;
&#xD;
      Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or&#xD;
      obesity. However, a mismatch exists between incidence forecasts and actual risk factors&#xD;
      knowledge. Several hypothesis plead for an environnemental cause.&#xD;
&#xD;
      Plant protection products oncogenetic effects are known and have been proved to be&#xD;
      responsible for tumors, including haematological malignancies. Its role in pancreatic&#xD;
      carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to&#xD;
      conclude for causality. Organochlorines is a specific subset of plant protection product that&#xD;
      store in lipids during lifetime.&#xD;
&#xD;
      The aim is to study association between organochlorine concentration in adipose tissue with&#xD;
      pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unicentric prospective case control study comparing organochlorine levels including patients&#xD;
      diagnosed with a pancreatic adenocarcinoma undergoing a surgery allowing to collect an&#xD;
      adipose tissue sample (10g).&#xD;
&#xD;
      Controls are adults with no pancreatic cancer (excluded by a 6 months old computed tomography&#xD;
      excluding the probability of a pancreatic neoplasm), paired with cases upon age and body mass&#xD;
      index, with a scheduled surgical procedure allowing to collect an adipose tissue sample&#xD;
      without extending procedure length.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">September 12, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 12, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adipose tissue organochlorine concentration</measure>
    <time_frame>Day 0</time_frame>
    <description>QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine organochlorine concentration</measure>
    <time_frame>Day 0</time_frame>
    <description>Use of Agilent 7010 Detection limit : 0.1microg/L</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Carcinoma</condition>
  <condition>Pancreatic Ductal</condition>
  <arm_group>
    <arm_group_label>Group &quot;Cases&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with pancreatic adenocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group &quot;Controls&quot;</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients without pancreatic adenocarcinoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adipose tissue sampling during surgery and urine sampling</intervention_name>
    <description>Adipose tissue sampling during surgery and urine sampling</description>
    <arm_group_label>Group &quot;Cases&quot;</arm_group_label>
    <arm_group_label>Group &quot;Controls&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria :&#xD;
&#xD;
        Cases :&#xD;
&#xD;
          -  patients diagnosed with a pancreatic adenocarcinoma, all stages allowed&#xD;
&#xD;
          -  undergoing a surgery allowing to take a 10 grams adipose tissue sample&#xD;
&#xD;
        Controls :&#xD;
&#xD;
          -  patients without a pancreatic neoplasm on a 6 months old CT scan before inclusion&#xD;
&#xD;
          -  undergoing a surgery allowing to take a 10 grams adipose tissue sample&#xD;
&#xD;
        exclusion criteria :&#xD;
&#xD;
        Cases :&#xD;
&#xD;
          -  patients diagnosed with a pancreatic adenocarcinoma developed on IPMN or cystadenoma&#xD;
&#xD;
          -  patient with a known genetic predisposition increasing pancreatic adenocarcinoma risk&#xD;
&#xD;
          -  histopathology proof of a mixed neuroendocrine neoplasm&#xD;
&#xD;
          -  no surgery allowing to take a 10 grams adipose tissue sample&#xD;
&#xD;
        Controls :&#xD;
&#xD;
          -  patients with a pancreatic neoplasm on a 6 months old CT scan before inclusion&#xD;
&#xD;
          -  no surgery allowing to take a 10 grams adipose tissue sample&#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_contact>
    <last_name>Olivier BOUCHE</last_name>
    <phone>03 26 78 31 13</phone>
    <phone_ext>0033</phone_ext>
    <email>obouche@chu-reims.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Damien JOLLY</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier BOUCHE</last_name>
      <phone>03 26 78 31 13</phone>
      <phone_ext>0033</phone_ext>
      <email>obouche@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plant production products</keyword>
  <keyword>risk factor</keyword>
  <keyword>adipose tissue</keyword>
  <keyword>organochlorine</keyword>
  <keyword>pesticides</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</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/NCT04429490
org study id: PA20035
nct id: NCT04429490
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new
      cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in
      Grand Est region. National incidence has doubled for men and tripled for women between 1982
      and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all
      stages 5-year survival. It will become the second deadliest in Europe, behind
      bronchopulmonary cancer.

      Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or
      obesity. However, a mismatch exists between incidence forecasts and actual risk factors
      knowledge. Several hypothesis plead for an environnemental cause.

      Plant protection products oncogenetic effects are known and have been proved to be
      responsible for tumors, including haematological malignancies. Its role in pancreatic
      carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to
      conclude for causality. Organochlorines is a specific subset of plant protection product that
      store in lipids during lifetime.

      The aim is to study association between organochlorine concentration in adipose tissue with
      pancreatic adenocarcinoma.
Unicentric prospective case control study comparing organochlorine levels including patients
      diagnosed with a pancreatic adenocarcinoma undergoing a surgery allowing to collect an
      adipose tissue sample (10g).

      Controls are adults with no pancreatic cancer (excluded by a 6 months old computed tomography
      excluding the probability of a pancreatic neoplasm), paired with cases upon age and body mass
      index, with a scheduled surgical procedure allowing to collect an adipose tissue sample
      without extending procedure length.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Adipose tissue organochlorine concentration
time frame: Day 0
description: QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue
measure: Urine organochlorine concentration
time frame: Day 0
description: Use of Agilent 7010 Detection limit : 0.1microg/L
arm group label: Group "Cases"
arm group type: Experimental
description: patients with pancreatic adenocarcinoma
arm group label: Group "Controls"
arm group type: Other
description: patients without pancreatic adenocarcinoma
intervention type: Other
intervention name: Adipose tissue sampling during surgery and urine sampling
description: Adipose tissue sampling during surgery and urine sampling
arm group label: Group "Cases"
arm group label: Group "Controls"
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier BOUCHE
phone: 03 26 78 31 13
phone ext: 0033
email: obouche@chu-reims.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma