<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/NCT03772002</url>
  </required_header>
  <id_info>
    <org_study_id>IN-CN-987-5343</org_study_id>
    <nct_id>NCT03772002</nct_id>
  </id_info>
  <brief_title>Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu</brief_title>
  <official_title>Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
      Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of&#xD;
      people with chronic hepatitis C (CHC) infection knowing their status. The major challenges&#xD;
      are that awareness is lacking, reliable diagnostics and testing services are not sufficiently&#xD;
      available, and laboratory capacity is weak. In the context of major tertiary hospitals, the&#xD;
      well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the&#xD;
      identification of inpatients who are unaware of HCV infection. However, given the preliminary&#xD;
      data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly&#xD;
      low. A recent study from a major hospital in Jilin province of China showed that 3.36% of&#xD;
      inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further&#xD;
      performed in this study.&#xD;
&#xD;
      From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during&#xD;
      2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA&#xD;
      confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that&#xD;
      insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive&#xD;
      anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the&#xD;
      infectious department in Chinese hospitals are relative independent from non-ID departments,&#xD;
      meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians.&#xD;
      Therefore, an appropriate clinical pathway for integration and linkage of non-ID department&#xD;
      and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The&#xD;
      investigator aim to establish a feasible clinical pathway and consensus guideline to enhance&#xD;
      HCV testing surveillance with linkage to care in non-ID departments. Moreover, the&#xD;
      participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which&#xD;
      the intervention and clinical outcome of hepatitis will be longitudinally monitored in the&#xD;
      future study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of CHC patients linked to care in non-infectious departments.</measure>
    <time_frame>1 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.</measure>
    <time_frame>1 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The referral rate of identified HCV infected patients.</measure>
    <time_frame>1 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>HCV screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HCV screening</intervention_name>
    <description>HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment</description>
    <arm_group_label>HCV screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Retrospective cohort:&#xD;
&#xD;
          1. ≥ 18 years of age.&#xD;
&#xD;
          2. Inpatients from non-infectious department.&#xD;
&#xD;
          3. Documentation of laboratory test indicating positive HCV antibody.&#xD;
&#xD;
        Prospective cohort:&#xD;
&#xD;
          1. ≥ 18 years of age.&#xD;
&#xD;
          2. Inpatients from non-infectious departments.&#xD;
&#xD;
          3. Patients who meet the requirement of HCV antibody screening:&#xD;
&#xD;
               1. patients with high risk possibility of HCV infection.&#xD;
&#xD;
               2. patients who will have special or invasive medical operation.&#xD;
&#xD;
               3. patients with unexplained abnormal liver biochemical laboratory results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Retrospective cohort: Duplicated subjects.&#xD;
&#xD;
        Prospective cohort：Inability or unwillingness to provide informed consent or abide by the&#xD;
        requirements of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chao Wu, M.D, Ph.D.</last_name>
    <phone>86-25-83105890</phone>
    <email>dr.wu@nju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuxin Chen, Ph.D.</last_name>
    <phone>86-25-83105890</phone>
    <email>yuxin_chen2015@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Third Hospital of Changzhou</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213001</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Longgen Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Chao Wu, M.D, Ph.D</last_name>
      <phone>86-25-83105890</phone>
      <email>dr.wu@nju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Chao Wu</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</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/NCT03772002
org study id: IN-CN-987-5343
nct id: NCT03772002
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of
      people with chronic hepatitis C (CHC) infection knowing their status. The major challenges
      are that awareness is lacking, reliable diagnostics and testing services are not sufficiently
      available, and laboratory capacity is weak. In the context of major tertiary hospitals, the
      well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the
      identification of inpatients who are unaware of HCV infection. However, given the preliminary
      data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly
      low. A recent study from a major hospital in Jilin province of China showed that 3.36% of
      inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further
      performed in this study.

      From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during
      2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA
      confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that
      insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive
      anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the
      infectious department in Chinese hospitals are relative independent from non-ID departments,
      meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians.
      Therefore, an appropriate clinical pathway for integration and linkage of non-ID department
      and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The
      investigator aim to establish a feasible clinical pathway and consensus guideline to enhance
      HCV testing surveillance with linkage to care in non-ID departments. Moreover, the
      participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which
      the intervention and clinical outcome of hepatitis will be longitudinally monitored in the
      future study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.
time frame: 1 years
measure: The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.
time frame: 1 years
measure: The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.
time frame: 1 years
measure: The percentage of CHC patients linked to care in non-infectious departments.
time frame: 1 years
measure: The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.
time frame: 1 years
measure: The referral rate of identified HCV infected patients.
time frame: 1 years
arm group label: HCV screening
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: HCV screening
description: HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment
arm group label: HCV screening
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chao Wu, M.D, Ph.D.
phone: 86-25-83105890
email: dr.wu@nju.edu.cn
last name: Yuxin Chen, Ph.D.
phone: 86-25-83105890
email: yuxin_chen2015@163.com
facility: 
contact: 
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Chao Wu
investigator title: Prof.
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
sharing ipd: Undecided