<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/NCT03032913</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2015/26</org_study_id>
    <nct_id>NCT03032913</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC</brief_title>
  <acronym>PANC-CTC</acronym>
  <official_title>Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis&#xD;
      of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry&#xD;
      the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will&#xD;
      examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of&#xD;
      patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the&#xD;
      past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is&#xD;
      currently available for this deadly disease, with an overall survival &lt;5%. Survival can reach&#xD;
      20% when surgery is possible, giving the best chance to the patients. If patients present&#xD;
      locally advance disease, it is crucial to quickly establish resectability to avoid unneeded&#xD;
      and even deleterious surgery in patients with metastatic stages. It is also important to&#xD;
      increase the rate of true R0 resection with effective preoperative therapy. However, when the&#xD;
      cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory&#xD;
      histologic proof is difficult to make with non-informative biopsies. It is necessary to find&#xD;
      new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery&#xD;
      when anatomo-pathologic proof is not available. New developments in the field of liquid&#xD;
      biopsy hold great promise in providing valuable information for diagnosis assistance. The&#xD;
      project will be run in two steps. First, several methods will be compared for tumor cell&#xD;
      recovery after cell spiking in blood of non-cancer patients and pancreatic cell line&#xD;
      onco-exosomes will characterized by flow cytometry. Second the best method will be used to&#xD;
      detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+&#xD;
      exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established&#xD;
      and compared. Correlations between circulating tumor elements presence and clinical and&#xD;
      biological parameters will be evaluated at the time of the diagnosis. Patient clinical&#xD;
      outcome will be assessed according to initial circulating element quantification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">November 13, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Step 1: reproducibility of CTC detection with the 3 methods</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma (PDAC)</condition>
  <arm_group>
    <arm_group_label>Pancreatic ductal adenocarcinoma patients</arm_group_label>
    <description>Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-cancer patients</arm_group_label>
    <description>Patients with no Cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Blood samples for both group</description>
    <arm_group_label>Non-cancer patients</arm_group_label>
    <arm_group_label>Pancreatic ductal adenocarcinoma patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Portal vein blood sample</intervention_name>
    <description>Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group</description>
    <arm_group_label>Pancreatic ductal adenocarcinoma patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with&#xD;
        no cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with informed consent&#xD;
&#xD;
          -  Patient with health care coverage&#xD;
&#xD;
          -  Group of PDAC patients: Patient with resectable lesion with suspicion or recent&#xD;
             diagnosis of PDAC recruited in the surgery department&#xD;
&#xD;
          -  Group of non-cancer patients: Patients in the surgery department without cancer&#xD;
             lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or&#xD;
             sleeve gastrectomy procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 or under tutelage&#xD;
&#xD;
          -  Patient with recent chemotherapy or radiotherapy&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  Patient with negative or non-informative biopsy&#xD;
&#xD;
          -  Patient with technically unserectable disease&#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>Etienne BUSCAIL</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>Pancreatic</keyword>
  <keyword>Cancer</keyword>
  <keyword>Circulating tumor cell (CTC)</keyword>
  <keyword>Adenocarcinoma</keyword>
  <keyword>Ductal</keyword>
  <keyword>Exosome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03032913
org study id: CHUBX 2015/26
nct id: NCT03032913
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis
      of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry
      the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will
      examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of
      patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.
Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the
      past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is
      currently available for this deadly disease, with an overall survival <5%. Survival can reach
      20% when surgery is possible, giving the best chance to the patients. If patients present
      locally advance disease, it is crucial to quickly establish resectability to avoid unneeded
      and even deleterious surgery in patients with metastatic stages. It is also important to
      increase the rate of true R0 resection with effective preoperative therapy. However, when the
      cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory
      histologic proof is difficult to make with non-informative biopsies. It is necessary to find
      new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery
      when anatomo-pathologic proof is not available. New developments in the field of liquid
      biopsy hold great promise in providing valuable information for diagnosis assistance. The
      project will be run in two steps. First, several methods will be compared for tumor cell
      recovery after cell spiking in blood of non-cancer patients and pancreatic cell line
      onco-exosomes will characterized by flow cytometry. Second the best method will be used to
      detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+
      exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established
      and compared. Correlations between circulating tumor elements presence and clinical and
      biological parameters will be evaluated at the time of the diagnosis. Patient clinical
      outcome will be assessed according to initial circulating element quantification.
observational model: Cohort
time perspective: Prospective
measure: Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments
time frame: 6 months
measure: Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.
time frame: 18 months
measure: Step 1: reproducibility of CTC detection with the 3 methods
time frame: 6 months
description: Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.
measure: Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome
time frame: 18 months
arm group label: Pancreatic ductal adenocarcinoma patients
description: Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC
arm group label: Non-cancer patients
description: Patients with no Cancer
intervention type: Procedure
intervention name: Blood samples
description: Blood samples for both group
arm group label: Non-cancer patients
arm group label: Pancreatic ductal adenocarcinoma patients
intervention type: Procedure
intervention name: Portal vein blood sample
description: Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group
arm group label: Pancreatic ductal adenocarcinoma patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Etienne BUSCAIL
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Neoplastic Cells, Circulating
sharing ipd: No