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/NCT06036992</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC22.0232 - COMPLIK</org_study_id>
      <nct_id>NCT06036992</nct_id>
    </id_info>
    <brief_title>Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease</brief_title>
    <acronym>COMPLIK</acronym>
    <official_title>Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Brest</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>
        Autosomal dominant polycystic kidney disease is characterised by the development of renal and&#xD;
        hepatic cysts. While the main complication is chronic end-stage renal failure, specific&#xD;
        cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst&#xD;
        infections, cyst-related mechanical complications and lithiasis. To date, there is no&#xD;
        reliable epidemiological data on the frequency and clinical impact of these complications.&#xD;
        Diagnosis of these complications is often complicated, and their management has not been&#xD;
        codified. The latest international recommendations (KDIGO) provide only low-level&#xD;
        recommendations. For the most complex cases (recurrent cystic infections, resistant pain,&#xD;
        mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.),&#xD;
        practitioners are often at a loss and management varies greatly from one centre to another.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Autosomal dominant polycystic kidney disease is characterised by the development of renal and&#xD;
        hepatic cysts. While the main complication is chronic end-stage renal failure, specific&#xD;
        cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst&#xD;
        infections, cyst-related mechanical complications and lithiasis. To date, there is no&#xD;
        reliable epidemiological data on the frequency and clinical impact of these complications.&#xD;
        Diagnosis of these complications is often complicated, and their management has not been&#xD;
        codified. The latest international recommendations (KDIGO) provide only low-level&#xD;
        recommendations. For the most complex cases (recurrent cystic infections, resistant pain,&#xD;
        mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.),&#xD;
        practitioners are often at a loss and management varies greatly from one centre to another.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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 improve knowledge of the epidemiology of cystic complications within the Genkyst network</measure>
      <time_frame>12 months</time_frame>
      <description>number of cases of cystic complications per year per complication</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Creation of a specific multidisciplinary consultation meeting</measure>
      <time_frame>12 months</time_frame>
      <description>Meetings and exchanges between different health professionals: interventional radiologists, surgeons, infectiologists, hepatologists, pain specialists and nephrologists to discuss the best possible management for patients with complex cystic complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creation of an image bank</measure>
      <time_frame>12 months</time_frame>
      <description>consulting images to recalculate and improve diagnostic scores</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creation of a group of control patients</measure>
      <time_frame>12 months</time_frame>
      <description>the change from baseline in quality of life scores at 1 year.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Polycystic Kidney Diseases</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with autosomal dominant polycystic kidney disease included in Genkyst who present&#xD;
          at least one cystic complication.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with autosomal dominant polycystic kidney disease (APKD) participating in the&#xD;
               Genkyst study&#xD;
  &#xD;
            -  Patient with at least one cystic complication. The cystic complications retained are&#xD;
               the following:&#xD;
  &#xD;
                 -  Acute or chronic cyst-related pain requiring analgesic treatments&#xD;
  &#xD;
                 -  Cyst infection&#xD;
  &#xD;
                 -  Intracystic haemorrhage&#xD;
  &#xD;
                 -  Urinary lithiasis&#xD;
  &#xD;
                 -  Functional complaints related to the cystic mass: digestive disorders with eating&#xD;
                    disorders, undernutrition, diaphragmatic compression phenomena, portal&#xD;
                    hypertension, umbilical or linea alba hernias, ventrations&#xD;
  &#xD;
                 -  Need for a cystic reduction procedure: puncture, marsupialization, open surgery&#xD;
                    (including preparation for grafting)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have expressed their opposition to taking part in the study&#xD;
  &#xD;
            -  Patient under legal protection (guardianship, curatorship, etc.)&#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>Yannick LE MEUR</last_name>
      <phone>02 98 34 70 74</phone>
      <phone_ext>+33</phone_ext>
      <email>yannick.lemeur@chu-brest.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christelle GUILLERM-REGOST</last_name>
      <phone>02 98 34 78 90</phone>
      <phone_ext>+33</phone_ext>
      <email>christelle.guillerm-regost@chu-brest.fr</email>
    </overall_contact_backup>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Kidney Diseases</mesh_term>
      <mesh_term>Polycystic Kidney Diseases</mesh_term>
      <mesh_term>Polycystic Kidney, Autosomal Dominant</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning three years and ending fifteen years following the final study report completion</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
    </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/NCT06036992
  org study id: 29BRC22.0232 - COMPLIK
  nct id: NCT06036992
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Autosomal dominant polycystic kidney disease is characterised by the development of renal and
        hepatic cysts. While the main complication is chronic end-stage renal failure, specific
        cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst
        infections, cyst-related mechanical complications and lithiasis. To date, there is no
        reliable epidemiological data on the frequency and clinical impact of these complications.
        Diagnosis of these complications is often complicated, and their management has not been
        codified. The latest international recommendations (KDIGO) provide only low-level
        recommendations. For the most complex cases (recurrent cystic infections, resistant pain,
        mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.),
        practitioners are often at a loss and management varies greatly from one centre to another.
  Autosomal dominant polycystic kidney disease is characterised by the development of renal and
        hepatic cysts. While the main complication is chronic end-stage renal failure, specific
        cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst
        infections, cyst-related mechanical complications and lithiasis. To date, there is no
        reliable epidemiological data on the frequency and clinical impact of these complications.
        Diagnosis of these complications is often complicated, and their management has not been
        codified. The latest international recommendations (KDIGO) provide only low-level
        recommendations. For the most complex cases (recurrent cystic infections, resistant pain,
        mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.),
        practitioners are often at a loss and management varies greatly from one centre to another.
  observational model: Cohort
  time perspective: Prospective
  measure: To improve knowledge of the epidemiology of cystic complications within the Genkyst network
  time frame: 12 months
  description: number of cases of cystic complications per year per complication
  measure: Creation of a specific multidisciplinary consultation meeting
  time frame: 12 months
  description: Meetings and exchanges between different health professionals: interventional radiologists, surgeons, infectiologists, hepatologists, pain specialists and nephrologists to discuss the best possible management for patients with complex cystic complications.
  measure: Creation of an image bank
  time frame: 12 months
  description: consulting images to recalculate and improve diagnostic scores
  measure: Creation of a group of control patients
  time frame: 12 months
  description: the change from baseline in quality of life scores at 1 year.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yannick LE MEUR
  phone: 02 98 34 70 74
  phone ext: +33
  email: yannick.lemeur@chu-brest.fr
  last name: Christelle GUILLERM-REGOST
  phone: 02 98 34 78 90
  phone ext: +33
  email: christelle.guillerm-regost@chu-brest.fr
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Polycystic Kidney Diseases
  mesh term: Polycystic Kidney, Autosomal Dominant
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.