<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/NCT03838913</url>
  </required_header>
  <id_info>
    <org_study_id>Fujian Provincial Hospital</org_study_id>
    <nct_id>NCT03838913</nct_id>
  </id_info>
  <brief_title>Whole-Exome Sequencing (WES) of Intraductal Neoplasms of the Bile Duct (IPNB)</brief_title>
  <acronym>WESIPNB</acronym>
  <official_title>Classification of Mutation Characteristics by Whole-Exome Sequencing (WES) in Intraductal Neoplasms of the Bile Duct (IPNB) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fujian Provincial 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>
      Intraductal papillary neoplasm of the bile duct (IPNB) is a distinct type of biliary tumor&#xD;
      characterised with delicate fibrovascular stalks (papillary of villous) covered at biliary&#xD;
      epithelium. The typical pathologic feature is dramatical dilation of affected bile ducts due&#xD;
      to obstruction by mucin production. IPNB has a better prognosis than bile duct carcinoma, but&#xD;
      the current proposed entity contains multiple definitions or categories, thus confused in&#xD;
      pathology.&#xD;
&#xD;
      Although mutations of several genes on IPNBs (such as GNAS, KRAS, APC, CTNNB1, and RNF43)&#xD;
      identified in previous studies, there is still an unification at gene expression signature.&#xD;
&#xD;
      This research trial will use whole exome sequencing and subsequent bioinformatic analysis in&#xD;
      finding causative mutations in deoxyribonucleic acid (DNA) samples from IPNBs patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using production-scale platform, this study will carry out whole exome sequencing from&#xD;
      archival (FFPE) material to Identification and classification of significantly mutated genes,&#xD;
      determine the somatic genomic alterations that may be relevant to the development or&#xD;
      treatment of cancer, establish classification of IPNBs gene mutation signature. Next,&#xD;
      analysis of gene mutation signature and IPNBs clinicopathologic outcomes, including the&#xD;
      association between pathologic type, long-term oncological outcomes and gene mutation&#xD;
      signature. Last, the determination of involved signal pathways at IPNB patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of novel genetic contributors to IPNBs</measure>
    <time_frame>1 year</time_frame>
    <description>Novel genetic abnormalities that are found to be associated with IPNBs via production-scale platform for whole exome sequencing from archival (FFPE) material. The tumor and normal specimens will be obtained from patients with IPNBs who are receiving treatment at Fujian Provincial Hospital, Fujian Medical University Union Hospital and First affiliated Hospital of Fujian Medical University.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation of WES outcomes</measure>
    <time_frame>1 year</time_frame>
    <description>To precise determination of mutation signature of WES results by Sanger Sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of involved signal pathways</measure>
    <time_frame>1 year</time_frame>
    <description>To predict and verify the involved signal pathways by bioinformatics</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bile Duct Neoplasms</condition>
  <condition>Intraductal Papillary Mucinous Neoplasm</condition>
  <arm_group>
    <arm_group_label>IPNB</arm_group_label>
    <description>intraductal papillary neoplasm of the bile duct</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        60 cases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of IPNBs&#xD;
&#xD;
          -  ECOG Performance status of 0, 1, or 2&#xD;
&#xD;
          -  Adequate liver function, bilirubin &lt; 1.5 times ULN, ALT or AST &lt; 2.5 times ULN&#xD;
&#xD;
          -  Adequate renal function: creatinine &lt; 1.8&#xD;
&#xD;
          -  Must be at least 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of hepatic mucinous cystadenoma (MCN)&#xD;
&#xD;
          -  Complicated with other Malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaodong Wang, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Provincial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yaodong Wang, Prof</last_name>
    <phone>18105010560</phone>
    <phone_ext>18105010560</phone_ext>
    <email>nanfangg@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yaodong Wang</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yaodong Wang</last_name>
      <phone>18105010560</phone>
      <phone_ext>18105010560</phone_ext>
      <email>nanfangg@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Yaodong Wang</investigator_full_name>
    <investigator_title>Director of Dept. Hepatobiliary Surgery</investigator_title>
  </responsible_party>
  <keyword>Whole-exome Sequencing</keyword>
  <keyword>intraductal papillary neoplasms of the bile duct</keyword>
  <keyword>mutation characteristics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Cystic, Mucinous, and Serous</mesh_term>
    <mesh_term>Bile Duct Neoplasms</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/NCT03838913
org study id: Fujian Provincial Hospital
nct id: NCT03838913
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Intraductal papillary neoplasm of the bile duct (IPNB) is a distinct type of biliary tumor
      characterised with delicate fibrovascular stalks (papillary of villous) covered at biliary
      epithelium. The typical pathologic feature is dramatical dilation of affected bile ducts due
      to obstruction by mucin production. IPNB has a better prognosis than bile duct carcinoma, but
      the current proposed entity contains multiple definitions or categories, thus confused in
      pathology.

      Although mutations of several genes on IPNBs (such as GNAS, KRAS, APC, CTNNB1, and RNF43)
      identified in previous studies, there is still an unification at gene expression signature.

      This research trial will use whole exome sequencing and subsequent bioinformatic analysis in
      finding causative mutations in deoxyribonucleic acid (DNA) samples from IPNBs patients.
Using production-scale platform, this study will carry out whole exome sequencing from
      archival (FFPE) material to Identification and classification of significantly mutated genes,
      determine the somatic genomic alterations that may be relevant to the development or
      treatment of cancer, establish classification of IPNBs gene mutation signature. Next,
      analysis of gene mutation signature and IPNBs clinicopathologic outcomes, including the
      association between pathologic type, long-term oncological outcomes and gene mutation
      signature. Last, the determination of involved signal pathways at IPNB patients.
observational model: Cohort
time perspective: Retrospective
measure: Identification of novel genetic contributors to IPNBs
time frame: 1 year
description: Novel genetic abnormalities that are found to be associated with IPNBs via production-scale platform for whole exome sequencing from archival (FFPE) material. The tumor and normal specimens will be obtained from patients with IPNBs who are receiving treatment at Fujian Provincial Hospital, Fujian Medical University Union Hospital and First affiliated Hospital of Fujian Medical University.
measure: Validation of WES outcomes
time frame: 1 year
description: To precise determination of mutation signature of WES results by Sanger Sequencing.
measure: Determination of involved signal pathways
time frame: 1 year
description: To predict and verify the involved signal pathways by bioinformatics
arm group label: IPNB
description: intraductal papillary neoplasm of the bile duct
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yaodong Wang, Prof
role: Principal Investigator
affiliation: Fujian Provincial Hospital
last name: Yaodong Wang, Prof
phone: 18105010560
phone ext: 18105010560
email: nanfangg@gmail.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Yaodong Wang
investigator title: Director of Dept. Hepatobiliary Surgery
mesh term: Neoplasms
mesh term: Neoplasms, Cystic, Mucinous, and Serous
mesh term: Bile Duct Neoplasms
sharing ipd: No