xml: <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/NCT05996666</url>
    </required_header>
    <id_info>
      <org_study_id>RSCD2022015P</org_study_id>
      <nct_id>NCT05996666</nct_id>
    </id_info>
    <brief_title>Primary Liver Cancer Early Detection</brief_title>
    <acronym>PRIMe-liver</acronym>
    <official_title>Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Hospital of Jilin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Guangzhou Burning Rock Dx Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The First Hospital of Jilin University</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>
        In the recently published multi-center, prospective, single-blind study (THUNDER study),&#xD;
        using the methylation signal in cfDNA isolated from the peripheral blood to detect the six&#xD;
        types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a&#xD;
        specificity of 98.9%. In this study, a multicenter, case-control study is designed to&#xD;
        establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to&#xD;
        detect primary liver cancer and further validate the performance of the model.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR</measure>
      <time_frame>2023.07.01-2023.12.30</time_frame>
      <description>Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Performance of the liver cancer early detection model in detecting liver cancer at early stage</measure>
      <time_frame>2023.07.01-2023.12.30</time_frame>
      <description>Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes</measure>
      <time_frame>2023.07.01-2023.12.30</time_frame>
      <description>Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance of liver cancer early detection model to differentiate non-liver cancers</measure>
      <time_frame>2023.07.01-2023.12.30</time_frame>
      <description>Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of currently used biomarkers for liver cancer detection</measure>
      <time_frame>2023.07.01-2023.12.30</time_frame>
      <description>Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">701</enrollment>
    <condition>Liver Cancer</condition>
    <arm_group>
      <arm_group_label>Liver cancer arm</arm_group_label>
      <description>Participants with new diagnosis of liver cancer, from whom blood samples will be collected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Benign diseases arm</arm_group_label>
      <description>Participants with benign diseases of cancer, from whom blood samples will be collected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy arm</arm_group_label>
      <description>Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interfering cancer arm</arm_group_label>
      <description>Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Liver-cancer early detection test</intervention_name>
      <description>Blood collection and liver-cancer early detection test</description>
      <arm_group_label>Benign diseases arm</arm_group_label>
      <arm_group_label>Healthy arm</arm_group_label>
      <arm_group_label>Interfering cancer arm</arm_group_label>
      <arm_group_label>Liver cancer arm</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants enrolled in this study included subjects with primary liver cancers, benign&#xD;
          liver diseases, interfering cancers, and healthy individuals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Inclusion Criteria for all participants&#xD;
  &#xD;
            -  Individuals aged 18-74 years old&#xD;
  &#xD;
            -  Individuals capable of giving signed and legally effective informed consent&#xD;
               voluntarily&#xD;
  &#xD;
          Inclusion Criteria for liver cancer participants:&#xD;
  &#xD;
            -  Individuals newly diagnosed with or suspected of having liver cancer (including&#xD;
               hepatocellular carcinoma [HCC], intrahepatic cholangiocarcinoma [ICC], and combined&#xD;
               hepatocellular-cholangiocarcinoma [cHCC-CCA]).&#xD;
  &#xD;
            -  Individuals without any anti-cancer therapy prior to blood sample collection.&#xD;
  &#xD;
          Inclusion Criteria for participants with benign liver diseases:&#xD;
  &#xD;
            -  Individuals newly diagnosed as benign liver diseases before blood sample collection&#xD;
  &#xD;
            -  Individuals without curative treatment for the disease before blood sample collection&#xD;
  &#xD;
          Inclusion Criteria for participants with interfering cancers:&#xD;
  &#xD;
            -  Individuals diagnosed with or suspected of having interfering cancer&#xD;
  &#xD;
            -  Individuals without any anti-cancer therapy prior to blood sample collection&#xD;
  &#xD;
          Inclusion Criteria for healthy participants:&#xD;
  &#xD;
            -  No cancer-related or other clinical symptoms 30 days prior to blood sample collection&#xD;
  &#xD;
            -  No prior history of benign liver diseases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Exclusion Criteria for All the Participants:&#xD;
  &#xD;
            -  Individuals cannot provide blood samples at the study-specified blood collection sites&#xD;
  &#xD;
            -  Pregnancy or lactating women&#xD;
  &#xD;
            -  Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow&#xD;
               transplant or stem cell transplant&#xD;
  &#xD;
            -  Recipients of blood transfusion within 7 days prior to blood sample collection&#xD;
  &#xD;
            -  Recipients of anti-infective treatment within 14 days prior to blood sample collection&#xD;
  &#xD;
            -  Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to&#xD;
               diseases other than cancer&#xD;
  &#xD;
            -  Individuals with a history of malignant tumor&#xD;
  &#xD;
          Exclusion Criteria for liver cancer participants:&#xD;
  &#xD;
            -  Known prior or current diagnosis of other types of malignancies or multiple primary&#xD;
               cancers&#xD;
  &#xD;
            -  No confirmed diagnosis of liver cancer after blood sample collection&#xD;
  &#xD;
          Exclusion Criteria for participants with benign liver diseases:&#xD;
  &#xD;
            -  Individuals with a confirmed diagnosis of a malignant tumor or precancerous lesion&#xD;
  &#xD;
            -  Individuals who cannot be diagnosed as having benign liver diseases after blood sample&#xD;
               collection&#xD;
  &#xD;
          Exclusion Criteria for participants with interfering cancers:&#xD;
  &#xD;
            -  Known prior or current diagnosis of other types of malignancies or multiple primary&#xD;
               cancers&#xD;
  &#xD;
            -  No confirmed diagnosis of any type of interfering cancers after blood sample&#xD;
               collection&#xD;
  &#xD;
          Exclusion Criteria for healthy participants:&#xD;
  &#xD;
            -  Prior or ongoing treatment of cancers within 3 years prior to blood sample collection&#xD;
  &#xD;
            -  Clinically significant or uncontrolled comorbidities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tian Yang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Eastern Hepatobiliary Surgery Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nanya Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Hospital of Jilin University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bo Liu</last_name>
      <phone>18840110641</phone>
      <email>liuboliubo1109@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shangli Cai</last_name>
      <phone>86 021 61631938</phone>
      <email>shangli.cai@brbiotech.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Jilin university first hospital</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bo Liu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Eastern Hepatobiliary Surgery Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lanqing Yao</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
      <investigator_full_name>Guoyue Lv</investigator_full_name>
      <investigator_title>Professor of Gastroenterology &amp; Hepatology</investigator_title>
    </responsible_party>
    <keyword>Early detection</keyword>
    <keyword>Liver cancer</keyword>
    <keyword>cell-free DNA (cfDNA)</keyword>
    <keyword>qPCR</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996666
  org study id: RSCD2022015P
  nct id: NCT05996666
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  In the recently published multi-center, prospective, single-blind study (THUNDER study),
        using the methylation signal in cfDNA isolated from the peripheral blood to detect the six
        types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a
        specificity of 98.9%. In this study, a multicenter, case-control study is designed to
        establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to
        detect primary liver cancer and further validate the performance of the model.
  observational model: Case-Control
  time perspective: Prospective
  measure: Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
  time frame: 2023.07.01-2023.12.30
  description: Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals
  measure: Performance of the liver cancer early detection model in detecting liver cancer at early stage
  time frame: 2023.07.01-2023.12.30
  description: Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative
  measure: Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes
  time frame: 2023.07.01-2023.12.30
  description: Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes
  measure: Performance of liver cancer early detection model to differentiate non-liver cancers
  time frame: 2023.07.01-2023.12.30
  description: Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer
  measure: Comparison of currently used biomarkers for liver cancer detection
  time frame: 2023.07.01-2023.12.30
  description: Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer
  arm group label: Liver cancer arm
  description: Participants with new diagnosis of liver cancer, from whom blood samples will be collected.
  arm group label: Benign diseases arm
  description: Participants with benign diseases of cancer, from whom blood samples will be collected.
  arm group label: Healthy arm
  description: Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected.
  arm group label: Interfering cancer arm
  description: Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected.
  intervention type: Device
  intervention name: Liver-cancer early detection test
  description: Blood collection and liver-cancer early detection test
  arm group label: Benign diseases arm
  arm group label: Healthy arm
  arm group label: Interfering cancer arm
  arm group label: Liver cancer arm
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 74 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tian Yang
  role: Principal Investigator
  affiliation: Eastern Hepatobiliary Surgery Hospital
  last name: Nanya Wang
  role: Principal Investigator
  affiliation: The First Hospital of Jilin University
  last name: Bo Liu
  phone: 18840110641
  email: liuboliubo1109@163.com
  last name: Shangli Cai
  phone: 86 021 61631938
  email: shangli.cai@brbiotech.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Hospital of Jilin University
  investigator full name: Guoyue Lv
  investigator title: Professor of Gastroenterology & Hepatology
  mesh term: Liver Neoplasms