<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/NCT03809247</url>
  </required_header>
  <id_info>
    <org_study_id>pancreatic diseases</org_study_id>
    <nct_id>NCT03809247</nct_id>
  </id_info>
  <brief_title>Microbial Diversity of Pancreatic Diseases</brief_title>
  <official_title>Microbial Diversity of Pancreatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</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>
      This study plans to analyze the digestive flora structure of the group of patients with&#xD;
      pancreatic cancer.&#xD;
&#xD;
      The investigators compared the microflora of pancreatic cancer with other pancreatic diseases&#xD;
      and healthy people，in order to obtatin the information of microbial community difference&#xD;
      among the different groups. Finally，the investigators hope to identify the potential&#xD;
      biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic&#xD;
      diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First, all the participants provided written informed consent for participating in the study.&#xD;
      And the collecting procedures have no intervention or impact on treatment measures.&#xD;
&#xD;
      Second,the samples are collected, including the stools, the peripheral blood, and other&#xD;
      digestive secretions. If the participants had surgical indications and received surgical&#xD;
      treatment, the surgical resections of tissues (including paraffin section) are also&#xD;
      collected.&#xD;
&#xD;
      Third, the participants were basically divided into three groups，cases with pancreatic&#xD;
      cancer, cases with other pancreatic diseases, and health volunteers.&#xD;
&#xD;
      Finally, the investigators compare the microflora , its metabolites or effects among the&#xD;
      different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues (&#xD;
      (including paraffin section)) and so on, and hope to identify the potential biomarker and&#xD;
      pathogenic mechanisms that causes the onset and progression of pancreatic diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>16sRNA and metagenomics</measure>
    <time_frame>12/2022</time_frame>
    <description>Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams).&#xD;
Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreatic Disease</condition>
  <arm_group>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <description>such as Pancreatic ductal adenocarcinoma, Pancreatic acinar adenocarcinoma, and so on.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other pancreatic diseases</arm_group_label>
    <description>such as chronic pancreatitis, Intraductal papillary mucinous neoplasm (IPMN); Solid pseudopapillary tumors (SPT); Serous cystic neoplasm (SCN); Pancreatic neuroendocrine neoplasm (P-NN); Mucinous cystic neoplasm (MCN) and so on.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collect stool，other digestive secretions，blood and tissue samples ( (including paraffin&#xD;
      section) and extract DNA .&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male / Female Age ≥ 3 years old, ≤ 85 years old;&#xD;
&#xD;
          -  After MDT discussion, routine surgery can be performed, and the postoperative&#xD;
             pathology is clear as pancreatic cancerand other pancreatic diseases;&#xD;
&#xD;
          -  No history of antibiotics for three months before surgery, no history of yogurt&#xD;
             containing probiotics.&#xD;
&#xD;
          -  There is no serious damage to heart, liver and kidney function.&#xD;
&#xD;
          -  After obtaining the consent and specimen collection, detailed screening found that&#xD;
             some cases with history of antibiotics or yogurt history in three months. This part of&#xD;
             the specimen was not discarded. As a second candidate research objects to study the&#xD;
             effect of antibiotics or yoghurt on the flora in the disease state.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 3 years old, ≤ 85 years old;&#xD;
&#xD;
          -  After MDT discussion, routine surgery or ERCP can be performed, and the postoperative&#xD;
             pathology is clear as pancreatic cancer and other pancreatic diseases;&#xD;
&#xD;
          -  There is no serious damage to heart, liver and kidney function;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are breast-feeding during pregnancy and after pregnancy;&#xD;
&#xD;
          -  Patients with evidence of sensory or motor neuropathy;&#xD;
&#xD;
          -  Those who have a clear cardiovascular disease, severe associated disease or active&#xD;
             infection, including known HIV infection;&#xD;
&#xD;
          -  Those who have a history of other cancers;&#xD;
&#xD;
          -  Those who are allergic to drugs or their excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei WANG, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei WANG, Dr.</last_name>
    <phone>+86-13761648121</phone>
    <phone_ext>671001</phone_ext>
    <email>wangwei_0306@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Wang</last_name>
      <phone>+86-13761648121</phone>
      <email>wangwei_0306@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>WeiWang</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Pancreatic Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Pancreatic Diseases</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/NCT03809247
org study id: pancreatic diseases
nct id: NCT03809247
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study plans to analyze the digestive flora structure of the group of patients with
      pancreatic cancer.

      The investigators compared the microflora of pancreatic cancer with other pancreatic diseases
      and healthy people，in order to obtatin the information of microbial community difference
      among the different groups. Finally，the investigators hope to identify the potential
      biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic
      diseases.
First, all the participants provided written informed consent for participating in the study.
      And the collecting procedures have no intervention or impact on treatment measures.

      Second,the samples are collected, including the stools, the peripheral blood, and other
      digestive secretions. If the participants had surgical indications and received surgical
      treatment, the surgical resections of tissues (including paraffin section) are also
      collected.

      Third, the participants were basically divided into three groups，cases with pancreatic
      cancer, cases with other pancreatic diseases, and health volunteers.

      Finally, the investigators compare the microflora , its metabolites or effects among the
      different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues (
      (including paraffin section)) and so on, and hope to identify the potential biomarker and
      pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
observational model: Other
time perspective: Retrospective
measure: 16sRNA and metagenomics
time frame: 12/2022
description: Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams).
Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.
arm group label: Pancreatic cancer
description: such as Pancreatic ductal adenocarcinoma, Pancreatic acinar adenocarcinoma, and so on.
arm group label: Other pancreatic diseases
description: such as chronic pancreatitis, Intraductal papillary mucinous neoplasm (IPMN); Solid pseudopapillary tumors (SPT); Serous cystic neoplasm (SCN); Pancreatic neuroendocrine neoplasm (P-NN); Mucinous cystic neoplasm (MCN) and so on.
Collect stool，other digestive secretions，blood and tissue samples ( (including paraffin
      section) and extract DNA .
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wei WANG, Dr.
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Wei WANG, Dr.
phone: +86-13761648121
phone ext: 671001
email: wangwei_0306@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: WeiWang
investigator title: Chief physician
mesh term: Pancreatic Neoplasms
mesh term: Pancreatic Diseases
sharing ipd: Undecided