<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/NCT02187432</url>
  </required_header>
  <id_info>
    <org_study_id>Eurocyst</org_study_id>
    <nct_id>NCT02187432</nct_id>
  </id_info>
  <brief_title>The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe</brief_title>
  <official_title>The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andreas L. Serra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant&#xD;
      polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational&#xD;
      cohort study has the potential to identify progression factors and biomarkers, and to assess&#xD;
      disease stage specific mortality, morbidity and health care costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and&#xD;
      to establish a large-scale observational cohort of ADPKD patients for the purpose of studying&#xD;
      the pathogenesis, rate of disease progression, progression rate modifiers, disease stage&#xD;
      specific morbidity, mortality, health economic issues and the predictive value of biomarkers&#xD;
      in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be&#xD;
      followed up for at least three years. The ADPKD reference center network across Europe and&#xD;
      the observational cohort study will enable European ADPKD researchers to gain insight into&#xD;
      the natural history, heterogeneity and associated complications of the disease as well as how&#xD;
      it affects the lives of patients across Europe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>disease progression</measure>
    <time_frame>participants will be followed annually for at least 3 years</time_frame>
    <description>Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QOL (Quality of Life)</measure>
    <time_frame>participants will be followed annually for at least 3 years</time_frame>
    <description>Evaluate and establish the level of disease impact on self-estimated health status, pain, QoL, socioeconomic status (SES), ADPKD-related health burden, health care resource use.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1100</enrollment>
  <condition>Autosomal Dominant Polycystic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>ADPKD</arm_group_label>
    <description>EuroCYST is and observational trail aiming to investigate disease progression across the different stages of disease and stage specific morbidity and mortality factors in a longitudinal observational multi center study and to evaluate the levels of and associations between the impacts of patients reported disease outcome (quality of life (QoL), pain, self-estimated health status, health burden).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The following samples will be collected: blood, spot urine and 24h urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 1,100 participants aged 18 and above with a diagnosis of ADPKD,&#xD;
        diagnosed via imaging and family history. The assessment of participants is based on&#xD;
        defined inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants ≥ 18 years;&#xD;
&#xD;
          -  Clinical diagnosis of ADPKD based on kidney imaging and family history;&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease&#xD;
             Epidemiology Collaboration(CKD-EPI)- formula);&#xD;
&#xD;
          -  Provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or&#xD;
             anticipated in the following 12 months after enrollment;&#xD;
&#xD;
          -  Participation in a clinical trial aiming to modify disease outcome one year or less&#xD;
             before enrollment in the EuroCYST study;&#xD;
&#xD;
          -  New York Heart Association (NYHA) stadium IV.&#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_official>
    <last_name>Andreas L Serra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andreas L Serra, MD</last_name>
    <email>a.serra@gmx.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Serra, MD, MPH</last_name>
    <email>a.serra@gmx.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yves Pirson, Prof</last_name>
      <email>yves.pirson@uclouvain.be</email>
    </contact>
    <investigator>
      <last_name>Yves Pirson, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charles University Prague</name>
      <address>
        <city>Prague</city>
        <zip>128 08</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vladimir Tesar, Prof</last_name>
      <email>vladimir.tesar@lf1.cuni.cz</email>
    </contact>
    <investigator>
      <last_name>Vladimir Tesar, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier universitaire de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yannick Le Meur, Prof</last_name>
      <email>yannick.lemeur@chu-brest.fr</email>
    </contact>
    <investigator>
      <last_name>Yannick Le Meur, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dominique Chaveau, Prof</last_name>
      <email>chauveau.d@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Dominique Chaveau, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Klemens Budde, Prof</last_name>
      <email>klemens.budde@charite.de</email>
    </contact>
    <investigator>
      <last_name>Klemens Budde, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kai-Uwe Eckardt, Prof</last_name>
      <email>Kai-Uwe.Eckardt@uk-erlangen.de</email>
    </contact>
    <investigator>
      <last_name>Kai-Uwe Eckardt, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79095</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anna Koettgen, MD</last_name>
      <email>anna.koettgen@uniklinik-freiburg.de</email>
    </contact>
    <investigator>
      <last_name>Anna Koettgen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto di Ricerche Farmacologiche &quot;Mario Negri&quot;</name>
      <address>
        <city>Bergamo</city>
        <zip>24126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giuseppe Remuzzi, Prof</last_name>
      <email>giuseppe.remuzzi@marionegri.it</email>
    </contact>
    <investigator>
      <last_name>Giuseppe Remuzzi, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ron Gansevoort, MD</last_name>
      <email>R.T.Gansevoort@int.umcg.nl</email>
    </contact>
    <investigator>
      <last_name>Ron Gansevoort, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fundació Puigvert</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Roser Torra, MD</last_name>
      <email>rtorra@fundacio-puigvert.es</email>
    </contact>
    <investigator>
      <last_name>Roser Torra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andreas L Serra, MD</last_name>
      <phone>+41 44 635 51 07</phone>
      <email>a.serra@gmx.ch</email>
    </contact>
    <investigator>
      <last_name>Andreas L Serra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istanbul School of Medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tefvik Ecder, Prof</last_name>
      <email>ecder@istanbul.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Tefvik Ecder, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cambridge, Cambridge Cancer Center</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0XY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Richard Sandford, Prof</last_name>
      <email>rns13@medschl.cam.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Richard Sandford, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2RX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Albert CM Ong, Prof</last_name>
      <email>a.ong@sheffield.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Albert CM Ong, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>February 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Andreas L. Serra</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney, Autosomal Dominant</mesh_term>
  </condition_browse>
  <!-- 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/NCT02187432
org study id: Eurocyst
nct id: NCT02187432
lead sponsor: 
has dmc: No
EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant
      polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational
      cohort study has the potential to identify progression factors and biomarkers, and to assess
      disease stage specific mortality, morbidity and health care costs.
The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and
      to establish a large-scale observational cohort of ADPKD patients for the purpose of studying
      the pathogenesis, rate of disease progression, progression rate modifiers, disease stage
      specific morbidity, mortality, health economic issues and the predictive value of biomarkers
      in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be
      followed up for at least three years. The ADPKD reference center network across Europe and
      the observational cohort study will enable European ADPKD researchers to gain insight into
      the natural history, heterogeneity and associated complications of the disease as well as how
      it affects the lives of patients across Europe.
observational model: Cohort
time perspective: Prospective
measure: disease progression
time frame: participants will be followed annually for at least 3 years
description: Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.
measure: QOL (Quality of Life)
time frame: participants will be followed annually for at least 3 years
description: Evaluate and establish the level of disease impact on self-estimated health status, pain, QoL, socioeconomic status (SES), ADPKD-related health burden, health care resource use.
arm group label: ADPKD
description: EuroCYST is and observational trail aiming to investigate disease progression across the different stages of disease and stage specific morbidity and mortality factors in a longitudinal observational multi center study and to evaluate the levels of and associations between the impacts of patients reported disease outcome (quality of life (QoL), pain, self-estimated health status, health burden).
The following samples will be collected: blood, spot urine and 24h urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas L Serra, MD
role: Principal Investigator
affiliation: University of Zurich
last name: Andreas L Serra, MD
email: a.serra@gmx.ch
last name: Andreas Serra, MD, MPH
email: a.serra@gmx.ch
facility: 
status: Not yet recruiting
contact: 
investigator: 
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status: Not yet recruiting
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status: Recruiting
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country: Belgium
country: Czech Republic
country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Switzerland
country: Turkey
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Andreas L. Serra
investigator title: MD
mesh term: Kidney Diseases
mesh term: Polycystic Kidney Diseases
mesh term: Polycystic Kidney, Autosomal Dominant