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/NCT05975216</url>
    </required_header>
    <id_info>
      <org_study_id>Relink</org_study_id>
      <nct_id>NCT05975216</nct_id>
    </id_info>
    <brief_title>Relinking Diagnosed But Untreated HCV Patients Back Into Care.</brief_title>
    <acronym>Relink</acronym>
    <official_title>Relinking Diagnosed But Untreated HCV Patients Back Into Care.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</source>
    <oversight_info>
      <has_dmc>No</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>
        Reintroduction of patients into a HCV infection care pathway after a positive chronic&#xD;
        hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.&#xD;
  &#xD;
        Gaining insight in the possible reasons why patients are lost in follow-up after positive&#xD;
        hepatitis C serology.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Retrospective data collection</measure>
      <time_frame>before contacting the patient</time_frame>
      <description>Prevalence of diagnosed but untreated HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prospective interventional study</measure>
      <time_frame>from first contact of the patient till 12 weeks after end of treatment.</time_frame>
      <description>To recall DBU patients by phone, e-mail or letter, trying to optimize treated and cured patients after recall</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reason lost in follow-up</measure>
      <time_frame>from first contact of the patient till 12 weeks after end of treatment.</time_frame>
      <description>Understanding the different reasons why patients were lost in follow-up with the aim of improving our hospital quality in the future:&#xD;
  Unaware of positive hep C serology&#xD;
  Follow-up or treatment in other centre&#xD;
  Refusal of previously proposed therapy&#xD;
  Other?</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Hepatitis C Virus Infection</condition>
    <arm_group>
      <arm_group_label>Diagnosed-but-untreated</arm_group_label>
      <description>Diagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Contact the patient</intervention_name>
      <description>Phone call, email or letter to contact the patient to relink them.</description>
      <arm_group_label>Diagnosed-but-untreated</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Positive hepatitis C serology with positive or unknown HCV RNA.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels&#xD;
               database&#xD;
  &#xD;
            -  ≥18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Positive HCV serology with negative HCV RNA&#xD;
  &#xD;
            -  Previously eradicated patients in UZ Brussel&#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>Silke François, Dr.</last_name>
      <phone>+32 2 477</phone>
      <phone_ext>9665</phone_ext>
      <email>silke.francois@uzbrussel.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Virgini Van Buggenhout</last_name>
      <phone>+32 2 477</phone>
      <phone_ext>5014</phone_ext>
      <email>virgini.vanbuggenhout@uzbrussel.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UZ Brussel</name>
        <address>
          <city>Brussel</city>
          <zip>1090</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silke François</last_name>
        <phone>+32 2 477</phone>
        <phone_ext>60 11</phone_ext>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Hepatitis C</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/NCT05975216
  org study id: Relink
  nct id: NCT05975216
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Reintroduction of patients into a HCV infection care pathway after a positive chronic
        hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.
  
        Gaining insight in the possible reasons why patients are lost in follow-up after positive
        hepatitis C serology.
  observational model: Other
  time perspective: Other
  measure: Retrospective data collection
  time frame: before contacting the patient
  description: Prevalence of diagnosed but untreated HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
  measure: Prospective interventional study
  time frame: from first contact of the patient till 12 weeks after end of treatment.
  description: To recall DBU patients by phone, e-mail or letter, trying to optimize treated and cured patients after recall
  measure: Reason lost in follow-up
  time frame: from first contact of the patient till 12 weeks after end of treatment.
  description: Understanding the different reasons why patients were lost in follow-up with the aim of improving our hospital quality in the future:
  Unaware of positive hep C serology
  Follow-up or treatment in other centre
  Refusal of previously proposed therapy
  Other?
  arm group label: Diagnosed-but-untreated
  description: Diagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
  intervention type: Other
  intervention name: Contact the patient
  description: Phone call, email or letter to contact the patient to relink them.
  arm group label: Diagnosed-but-untreated
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Silke François, Dr.
  phone: +32 2 477
  phone ext: 9665
  email: silke.francois@uzbrussel.be
  last name: Virgini Van Buggenhout
  phone: +32 2 477
  phone ext: 5014
  email: virgini.vanbuggenhout@uzbrussel.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Hepatitis C