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/NCT06011694</url>
    </required_header>
    <id_info>
      <org_study_id>NanjingShihejiyinTech</org_study_id>
      <nct_id>NCT06011694</nct_id>
    </id_info>
    <brief_title>The Jinling Cohort</brief_title>
    <official_title>A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing Shihejiyin Technology, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing Shihejiyin Technology, Inc.</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>
        The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible&#xD;
        individuals aged 45-75 in Nanjing China will be enrolled.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Its aim is to assess the performance and clinical utility of the Multi-omics liquid biopsy&#xD;
        MCED test MERCURY in an average risk Chinese population. Each participant will undergo&#xD;
        peripheral blood collection for MERCURY test, health questionnaires and annual routine&#xD;
        physical exams once a year for three consecutive years, then followed up two additional&#xD;
        years. The entire assess time is 60 months.&#xD;
  &#xD;
        The primary goals of the study is to evaluate sensitivity, specificity, positive/negative&#xD;
        predictive value and other performance of MERCURY test.&#xD;
  &#xD;
        The secondary goal of the study is (1) to evaluate how many cancer types the test MERCURY can&#xD;
        detect and TOO accuracy; (2) With MCED test and routine physical exams being conducted in&#xD;
        parallel for three years and following up for five years, the study allows to assess MERCURY&#xD;
        test can detect cancer how many years earlier than conventional methods, leading to its&#xD;
        clinical value evaluation of whether it can ensure reduction in late-stage cancer diagnosis;&#xD;
        (3) to evaluate participants' attitude and perception towards MCED blood test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2022</start_date>
    <completion_date type="Anticipated">May 15, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2027</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>To evaluate sensitivity, specificity, positive/negative predictive value and other performance measures of the multi-omics liquid biopsy test MERCURY for multi-cancer early detection in average risk population</measure>
      <time_frame>assessed up to 60 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate how many cancer types the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY can detect and TOO (tumor of origin) accuracy</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>To assess whether the TOO (tumor of origin) results predicted from the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY match with clinical diagnostic tumor types received from follow-up. Summarize the number of consistency and inconsistency to evaluate the prediction accuracy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess test MERCURY's efficiency and clinical utility in average risk population</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>To assess MERCURY test's lead-time relative to clinical diagnosis. With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods by comparing MERCURY test positive timepoint to tumor clinical diagnosis timepoint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate participants' attitude and perception towards MCED blood test</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>To compare the adherence to annual blood exams to reported SOC (standard of care) screening methods to see whether participants' perception towards MCED blood test</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15000</enrollment>
    <condition>Cancer</condition>
    <condition>Multi Cancer Early Screening</condition>
    <condition>Liquid Biopsy</condition>
    <arm_group>
      <arm_group_label>No Intervention</arm_group_label>
      <description>Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MERCURY test, health questionnaires and annual routine physical exams</intervention_name>
      <description>Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.</description>
      <arm_group_label>No Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          45 Years to 75 Years (Adult, Older Adult)，Each participant will undergo peripheral blood&#xD;
          collection for MERCURY test, health questionnaires and annual routine physical exams once a&#xD;
          year for three consecutive years, then followed up two additional years.&#xD;
  &#xD;
          No&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1、45-75 years of age; 2、Willing and able to undergo blood sample collection, health&#xD;
          questionnaires and annual routine physical exams once a year for three consecutive years;&#xD;
          3、Residents in Nanjing; 4、Fully understand the study and able to provide a written informed&#xD;
          consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women;&#xD;
  &#xD;
            2. Individuals who have history of cancer or current diagnosis of cancer;&#xD;
  &#xD;
            3. Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow&#xD;
               or stem cell transplant;&#xD;
  &#xD;
            4. Individulas who have blood transfusion within 30 days prior to the blood draw;&#xD;
  &#xD;
            5. Individuals who have an acute infection or inflammation within 14 days prior to the&#xD;
               blood draw;&#xD;
  &#xD;
            6. Individuals who have taken medication with anti-tumor effects within 30 days prior to&#xD;
               the blood draw;&#xD;
  &#xD;
            7. Individuals who will not be able to comply with the protocol procedures judged by&#xD;
               researchers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shao Yang, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>NanjingShihejiyin Technology Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shanshan Yang, Ph.D</last_name>
      <phone>8613585145836</phone>
      <email>admin@geneseeq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xuan Wang</last_name>
      <phone>8618392411194</phone>
      <email>cohortstudy@geneseeq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nanjing Jiangbei People's Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jianbei Huang</last_name>
        <phone>+8618951766697</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Fourth Affiliated Hospital of Nanjing Medical University</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuan Mao, Ph.D</last_name>
        <phone>+8613951918531</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Early Detection of Cancer</keyword>
    <keyword>MCED</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06011694
  org study id: NanjingShihejiyinTech
  nct id: NCT06011694
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible
        individuals aged 45-75 in Nanjing China will be enrolled.
  Its aim is to assess the performance and clinical utility of the Multi-omics liquid biopsy
        MCED test MERCURY in an average risk Chinese population. Each participant will undergo
        peripheral blood collection for MERCURY test, health questionnaires and annual routine
        physical exams once a year for three consecutive years, then followed up two additional
        years. The entire assess time is 60 months.
  
        The primary goals of the study is to evaluate sensitivity, specificity, positive/negative
        predictive value and other performance of MERCURY test.
  
        The secondary goal of the study is (1) to evaluate how many cancer types the test MERCURY can
        detect and TOO accuracy; (2) With MCED test and routine physical exams being conducted in
        parallel for three years and following up for five years, the study allows to assess MERCURY
        test can detect cancer how many years earlier than conventional methods, leading to its
        clinical value evaluation of whether it can ensure reduction in late-stage cancer diagnosis;
        (3) to evaluate participants' attitude and perception towards MCED blood test.
  observational model: Cohort
  time perspective: Prospective
  measure: To evaluate sensitivity, specificity, positive/negative predictive value and other performance measures of the multi-omics liquid biopsy test MERCURY for multi-cancer early detection in average risk population
  time frame: assessed up to 60 months
  measure: To evaluate how many cancer types the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY can detect and TOO (tumor of origin) accuracy
  time frame: assessed up to 60 months
  description: To assess whether the TOO (tumor of origin) results predicted from the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY match with clinical diagnostic tumor types received from follow-up. Summarize the number of consistency and inconsistency to evaluate the prediction accuracy
  measure: To assess test MERCURY's efficiency and clinical utility in average risk population
  time frame: assessed up to 60 months
  description: To assess MERCURY test's lead-time relative to clinical diagnosis. With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods by comparing MERCURY test positive timepoint to tumor clinical diagnosis timepoint.
  measure: To evaluate participants' attitude and perception towards MCED blood test
  time frame: assessed up to 60 months
  description: To compare the adherence to annual blood exams to reported SOC (standard of care) screening methods to see whether participants' perception towards MCED blood test
  arm group label: No Intervention
  description: Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.
  intervention type: Other
  intervention name: MERCURY test, health questionnaires and annual routine physical exams
  description: Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.
  arm group label: No Intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shao Yang, Ph.D
  role: Principal Investigator
  affiliation: NanjingShihejiyin Technology Inc.
  last name: Shanshan Yang, Ph.D
  phone: 8613585145836
  email: admin@geneseeq.com
  last name: Xuan Wang
  phone: 8618392411194
  email: cohortstudy@geneseeq.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No