<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/NCT04445532</url>
  </required_header>
  <id_info>
    <org_study_id>JS-2296</org_study_id>
    <nct_id>NCT04445532</nct_id>
  </id_info>
  <brief_title>Hepatobiliary Tumors Tissue Samples Acquisition</brief_title>
  <official_title>Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OrigiMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GeneCast Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>YuceBio Technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geneplus-Beijing Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College 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>
      Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of&#xD;
      great significance to find important prognostic markers and then screen out specific&#xD;
      subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control&#xD;
      participants also need to show the evolution of tumors and discover specific diagnostic&#xD;
      markers as a control group. Moreover, targeted therapy and immunotherapy make cancer&#xD;
      treatment enter a new field, but only part of patients achieve response rates and reach&#xD;
      clinical benefit. However, these drugs are expensive and can cause treatment-related adverse&#xD;
      events. Therefore, reliable biomarkers identification is needed to help predict the response&#xD;
      to these treatment options in order to screen patients with better responsiveness and avoid&#xD;
      wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors&#xD;
      more deeply and find meaningful therapeutic targets.&#xD;
&#xD;
      Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in&#xD;
      this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
        1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival&#xD;
           (OS);&#xD;
&#xD;
        2. Observe the evolution of tumors and discover specific diagnostic markers as a control&#xD;
           group.&#xD;
&#xD;
        3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted&#xD;
           immunotherapy for advanced hepatobiliary tumors;&#xD;
&#xD;
        4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and&#xD;
           find therapeutic targets&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 11, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</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>Collected samples</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multi-omics analysis to further type and find therapeutic targets</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Gallbladder Cancer</condition>
  <condition>Biliary Tract Cancer</condition>
  <condition>Liver Cancer</condition>
  <condition>Precancerous Condition</condition>
  <condition>Benign Hepatobiliary Disease</condition>
  <condition>Healthy, no Evidence of Disease</condition>
  <arm_group>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
    <description>benign or malignant hepatobiliary tumors patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <description>chronic hepatitis, cirrhosis, and healthy control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gene expression analysis</intervention_name>
    <description>Gene expression analysis</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genomic analysis</intervention_name>
    <description>Genomic analysis</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein expression analysis</intervention_name>
    <description>Protein expression analysis</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proteomic profiling</intervention_name>
    <description>Proteomic profiling</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Polymerase chain reaction</intervention_name>
    <description>Polymerase chain reaction</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mass spectrometry</intervention_name>
    <description>Mass spectrometry</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immunohistochemistry</intervention_name>
    <description>Immunohistochemistry</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metabolomics profiling</intervention_name>
    <description>Metabolomics profiling</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Methylation and epigenetic analysis</intervention_name>
    <description>Methylation and epigenetic analysis</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Liquid biopsy analysis</intervention_name>
    <description>Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory biomarker analysis</intervention_name>
    <description>Laboratory biomarker analysis (such as AFP, CA19-9, CEA)</description>
    <arm_group_label>Benign Hepatobiliary Disease</arm_group_label>
    <arm_group_label>hepatobiliary tumor patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue, blood, urine, feces, ascites, bile samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited&#xD;
        at Peking Union Medical College Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be older than 18 years old;&#xD;
&#xD;
          2. ECOG 0-2 points;&#xD;
&#xD;
          3. May have received treatment;&#xD;
&#xD;
          4. Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or&#xD;
             chronic hepatitis, cirrhosis, or healthy control participants;&#xD;
&#xD;
          5. Patients may have received or are about to undergo surgery, chemotherapy,&#xD;
             radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;&#xD;
&#xD;
          6. Patients understand and are willing to sign written informed consent documents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The doctor thinks it is not suitable to enter the group (mental disorder or poor&#xD;
             compliance, etc.)&#xD;
&#xD;
          2. Pregnant women;&#xD;
&#xD;
          3. Active or uncontrollable infections (fungi, bacteria, etc.);&#xD;
&#xD;
          4. Estimated survival time &lt;12 weeks;&#xD;
&#xD;
          5. If the patient is receiving chronic anticoagulant therapy, the anticoagulant&#xD;
             withdrawal should not be shorter than 3 days;&#xD;
&#xD;
          6. In the evaluation of the doctor, there is a risk of uncontrolled complications in the&#xD;
             biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haitao Zhao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>XiaoBo Yang, MD</last_name>
    <phone>+86-138-1167-5126</phone>
    <email>yangxiaobo67@pumch.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haitao Zhao, MD</last_name>
    <email>zhaoht@pumch.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences &amp; Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xu Yang, MD</last_name>
      <phone>+86 158-1066-7683</phone>
      <phone_ext>010-69156043</phone_ext>
      <email>yangxulcyx@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Haitao Zhao, MD</last_name>
      <email>zhaoht@pumch.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Xiaobo Yang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
    <mesh_term>Gallbladder Neoplasms</mesh_term>
    <mesh_term>Precancerous Conditions</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Liver Diseases</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/NCT04445532
org study id: JS-2296
nct id: NCT04445532
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of
      great significance to find important prognostic markers and then screen out specific
      subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control
      participants also need to show the evolution of tumors and discover specific diagnostic
      markers as a control group. Moreover, targeted therapy and immunotherapy make cancer
      treatment enter a new field, but only part of patients achieve response rates and reach
      clinical benefit. However, these drugs are expensive and can cause treatment-related adverse
      events. Therefore, reliable biomarkers identification is needed to help predict the response
      to these treatment options in order to screen patients with better responsiveness and avoid
      wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors
      more deeply and find meaningful therapeutic targets.

      Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in
      this study.
OBJECTIVES:

        1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival
           (OS);

        2. Observe the evolution of tumors and discover specific diagnostic markers as a control
           group.

        3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted
           immunotherapy for advanced hepatobiliary tumors;

        4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and
           find therapeutic targets
observational model: Cohort
time perspective: Prospective
measure: Collected samples
time frame: through study completion, an average of 5 years
description: Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers
measure: Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)
time frame: through study completion, an average of 5 years
measure: Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors
time frame: through study completion, an average of 5 years
measure: Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors
time frame: through study completion, an average of 5 years
measure: Multi-omics analysis to further type and find therapeutic targets
time frame: through study completion, an average of 5 years
arm group label: hepatobiliary tumor patients
description: benign or malignant hepatobiliary tumors patients
arm group label: Benign Hepatobiliary Disease
description: chronic hepatitis, cirrhosis, and healthy control
intervention type: Other
intervention name: Gene expression analysis
description: Gene expression analysis
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Genomic analysis
description: Genomic analysis
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Protein expression analysis
description: Protein expression analysis
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Proteomic profiling
description: Proteomic profiling
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Polymerase chain reaction
description: Polymerase chain reaction
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Mass spectrometry
description: Mass spectrometry
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Immunohistochemistry
description: Immunohistochemistry
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Metabolomics profiling
description: Metabolomics profiling
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Methylation and epigenetic analysis
description: Methylation and epigenetic analysis
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Liquid biopsy analysis
description: Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
intervention type: Other
intervention name: Laboratory biomarker analysis
description: Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
arm group label: Benign Hepatobiliary Disease
arm group label: hepatobiliary tumor patients
Tissue, blood, urine, feces, ascites, bile samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Haitao Zhao, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: XiaoBo Yang, MD
phone: +86-138-1167-5126
email: yangxiaobo67@pumch.cn
last name: Haitao Zhao, MD
email: zhaoht@pumch.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
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responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Biliary Tract Neoplasms
mesh term: Gallbladder Neoplasms
mesh term: Precancerous Conditions
mesh term: Digestive System Diseases
mesh term: Liver Diseases