<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/NCT03041662</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2:6</org_study_id>
    <nct_id>NCT03041662</nct_id>
  </id_info>
  <brief_title>Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)</brief_title>
  <acronym>PSC</acronym>
  <official_title>Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</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>
      This observational study of a national cohort of 600 Swedish PSC patients include yearly&#xD;
      MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions,&#xD;
      symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC&#xD;
      patients and provide future possibilities to evaluate biomarkers for prognosis and early&#xD;
      cancer detection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2011</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>cholangiocarcinoma</measure>
    <time_frame>10 yrs f-up</time_frame>
    <description>cholangiocarcinoma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>liver transplatation</measure>
    <time_frame>10 yrs f-up</time_frame>
    <description>liver transplatation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>10 yrs f-up</time_frame>
    <description>death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>biliary dysplasia</measure>
    <time_frame>10 yrs f-up</time_frame>
    <description>biliary dysplasia</description>
  </secondary_outcome>
  <enrollment type="Actual">620</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <condition>Cholangiocarcinoma</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MR/MRCP</intervention_name>
    <description>MR/MRCP</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        National Swedish cohort of PSC patients followed at 14 hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of PSC by MR/MRCP&#xD;
&#xD;
          -  Life expectancy &gt;1 year&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver transplantation or on the waiting list&#xD;
&#xD;
          -  Secondry SC&#xD;
&#xD;
          -  Diagnosis of CCA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karolinska University Hospital, Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Annika Bergquist</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</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/NCT03041662
org study id: 2011/2:6
nct id: NCT03041662
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study of a national cohort of 600 Swedish PSC patients include yearly
      MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions,
      symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC
      patients and provide future possibilities to evaluate biomarkers for prognosis and early
      cancer detection.
observational model: Cohort
time perspective: Prospective
measure: cholangiocarcinoma
time frame: 10 yrs f-up
description: cholangiocarcinoma
measure: liver transplatation
time frame: 10 yrs f-up
description: liver transplatation
measure: death
time frame: 10 yrs f-up
description: death
measure: biliary dysplasia
time frame: 10 yrs f-up
description: biliary dysplasia
intervention type: Diagnostic Test
intervention name: MR/MRCP
description: MR/MRCP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Annika Bergquist
investigator title: professor
mesh term: Cholangiocarcinoma
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing
sharing ipd: Undecided