<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/NCT03821909</url>
  </required_header>
  <id_info>
    <org_study_id>EPCE-1</org_study_id>
    <nct_id>NCT03821909</nct_id>
  </id_info>
  <brief_title>Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS</brief_title>
  <acronym>CTCs</acronym>
  <official_title>Acquisition of Portal Venous Circulating Tumor Cells and Exosomes From Patients With Pancreatic Cancer by Endoscopic Ultrasound: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ying Lv</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
      The investigators are going to explore the diagnostic and prognostic value of circulating&#xD;
      tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic&#xD;
      ultrasound in pancreatic cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low&#xD;
      diagnostic rate at the early stage, there is still a significant clinical need to determine&#xD;
      individualized tumor molecular profiles and personalized risk for recurrence. Circulating&#xD;
      tumor cells (CTCs) and exosomes from patients with primary tumors may hold promise in serving&#xD;
      as an informative biomarker to address this clinical need. Here in this study, the&#xD;
      investigators are going to explore the feasibility and safety of sampling portal venous blood&#xD;
      via endoscopic ultrasound (EUS), and detect portal venous CTCs and analyze mRNA markers of&#xD;
      exosomes by RNA-seq. The investigators aim to explore the potential molecular mechanisms in&#xD;
      tumor microenvironment and mechanisms of drug resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases</measure>
    <time_frame>08/01/2018-08/01/2020</time_frame>
    <description>In this study, the amount of the circulating tumor cells obtained from portal venous blood of suspected pancreatic masses patients will be determined by analyzing the expression of folate receptors. The investigators will compare the difference of the CTC amount between patients with pancreatic cancer and benign pancreatic diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases</measure>
    <time_frame>08/01/2018-08/01/2020</time_frame>
    <description>Exosomes will be acquisited from portal venous blood of patients with suspected pancreatic masses. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between patients with pancreatic cancer and benign pancreatic diseases. (The mRNA markers will be selected from RNA-seq results.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference of the amount of circulating tumor cells between portal venous and peripheral blood</measure>
    <time_frame>08/01/2018-08/01/2020</time_frame>
    <description>In this study, the amount of the circulating tumor cells obtained from portal venous blood and peripheral blood will be assessed for each patient respectively. The investigators will compare the difference of the CTC amount between portal venous blood and peripheral blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference of the exosomes between portal venous and peripheral blood</measure>
    <time_frame>08/01/2018-08/01/2020</time_frame>
    <description>Exosomes will be acquisited from portal venous blood and peripheral blood for each patient. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between portal venous and peripheral blood for each patient. (The mRNA markers will be selected from RNA-seq results.)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <description>Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign pancreatic diseases</arm_group_label>
    <description>Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology, e.g. PCLs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic ultrasound-guided protal venous blood sampling</intervention_name>
    <description>We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.</description>
    <arm_group_label>Benign pancreatic diseases</arm_group_label>
    <arm_group_label>Pancreatic cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with&#xD;
      suspected pancreatic masses, detect circulating tumor cells and analyze the mRNA markers of&#xD;
      the exosomes by RNA-seq.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suspected to have pancreatic masses who are going to receive EUS-FNA operations&#xD;
        for diagnostic purposes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged from 18 to 80 years-old&#xD;
&#xD;
          2. Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis&#xD;
&#xD;
          3. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received adjuvant chemotherapy and other anti-tumor treatments&#xD;
&#xD;
          2. Severe heart, lung, liver, kidney insufficiency, or severe bleeding disorders, severe&#xD;
             coagulopathy or local/systemic infections, other critical illnesses&#xD;
&#xD;
          3. Women who are planning to become pregnant or are pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying Lv, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shu Zhang, PhD</last_name>
    <phone>13770728926</phone>
    <phone_ext>+86</phone_ext>
    <email>zhangshu19900513@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying Lv, PhD</last_name>
    <phone>13770755008</phone>
    <phone_ext>+86</phone_ext>
    <email>lying1999@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangshu Han, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Ying Lv</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Portal venous blood</keyword>
  <keyword>Circulating tumor cells</keyword>
  <keyword>Exosome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03821909
org study id: EPCE-1
nct id: NCT03821909
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are going to explore the diagnostic and prognostic value of circulating
      tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic
      ultrasound in pancreatic cancer patients.
As the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low
      diagnostic rate at the early stage, there is still a significant clinical need to determine
      individualized tumor molecular profiles and personalized risk for recurrence. Circulating
      tumor cells (CTCs) and exosomes from patients with primary tumors may hold promise in serving
      as an informative biomarker to address this clinical need. Here in this study, the
      investigators are going to explore the feasibility and safety of sampling portal venous blood
      via endoscopic ultrasound (EUS), and detect portal venous CTCs and analyze mRNA markers of
      exosomes by RNA-seq. The investigators aim to explore the potential molecular mechanisms in
      tumor microenvironment and mechanisms of drug resistance.
observational model: Cohort
time perspective: Prospective
measure: The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases
time frame: 08/01/2018-08/01/2020
description: In this study, the amount of the circulating tumor cells obtained from portal venous blood of suspected pancreatic masses patients will be determined by analyzing the expression of folate receptors. The investigators will compare the difference of the CTC amount between patients with pancreatic cancer and benign pancreatic diseases.
measure: The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases
time frame: 08/01/2018-08/01/2020
description: Exosomes will be acquisited from portal venous blood of patients with suspected pancreatic masses. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between patients with pancreatic cancer and benign pancreatic diseases. (The mRNA markers will be selected from RNA-seq results.)
measure: The difference of the amount of circulating tumor cells between portal venous and peripheral blood
time frame: 08/01/2018-08/01/2020
description: In this study, the amount of the circulating tumor cells obtained from portal venous blood and peripheral blood will be assessed for each patient respectively. The investigators will compare the difference of the CTC amount between portal venous blood and peripheral blood.
measure: The difference of the exosomes between portal venous and peripheral blood
time frame: 08/01/2018-08/01/2020
description: Exosomes will be acquisited from portal venous blood and peripheral blood for each patient. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between portal venous and peripheral blood for each patient. (The mRNA markers will be selected from RNA-seq results.)
arm group label: Pancreatic cancer
description: Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology.
arm group label: Benign pancreatic diseases
description: Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology, e.g. PCLs.
intervention type: Procedure
intervention name: Endoscopic ultrasound-guided protal venous blood sampling
description: We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.
arm group label: Benign pancreatic diseases
arm group label: Pancreatic cancer
We will obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with
      suspected pancreatic masses, detect circulating tumor cells and analyze the mRNA markers of
      the exosomes by RNA-seq.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ying Lv, PhD
role: Principal Investigator
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
last name: Shu Zhang, PhD
phone: 13770728926
phone ext: +86
email: zhangshu19900513@126.com
last name: Ying Lv, PhD
phone: 13770755008
phone ext: +86
email: lying1999@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Ying Lv
investigator title: Professor
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided