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/NCT06041334</url>
    </required_header>
    <id_info>
      <org_study_id>35RC20_9746_SPINLESS</org_study_id>
      <secondary_id>IDRCB</secondary_id>
      <nct_id>NCT06041334</nct_id>
    </id_info>
    <brief_title>Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up</brief_title>
    <acronym>SPINLESS</acronym>
    <official_title>Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rennes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NeuroSphinx</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rennes 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>
        The aim of the study is to investigate known urinary biomarkers in order to determine whether&#xD;
        they can be predictive of a risk of damage to the upper urinary tract and therefore the&#xD;
        kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be&#xD;
        calculated using the Galloway score, based on the results of the urodynamic study and&#xD;
        retrograde urethrocystography, which all patients with spina bifida have regularly.&#xD;
  &#xD;
        The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2&#xD;
        (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has&#xD;
        not yet been demonstrated.&#xD;
  &#xD;
        Volunteers to take part in the study will have their biomarkers measured at the time of their&#xD;
        urodynamic assessment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>We will measure levels of the urinary biomarkers TIMP-2 and MMP-2 and we will report them to explain the Galloway score at the same time.</measure>
      <time_frame>1 day</time_frame>
      <description>We will use logistic regression, with the variable to be explained being the Galloway score ≤ 5 or &gt; 5 (a qualitative variable with 2 classes) and the rate of urinary biomarkers as the explanatory variable</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Spina Bifida</condition>
    <arm_group>
      <arm_group_label>Study volunteers</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Collection of a urine sample</intervention_name>
      <description>Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)</description>
      <arm_group_label>Study volunteers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnetic Resonance Imaging of the bladder</intervention_name>
      <description>Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)</description>
      <arm_group_label>Study volunteers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Spina patients consulted as part of the multidisciplinary consultation of the spina&#xD;
               bifida rare disease reference centre;&#xD;
  &#xD;
            -  Written consent to participate in the research.&#xD;
  &#xD;
            -  Compulsory membership of a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a non-continuous trans ileal urinary diversion ;&#xD;
  &#xD;
            -  Patients with enterocystoplasty;&#xD;
  &#xD;
            -  Untreated bacteriuria at the time of urodynamic assessment and urine sample&#xD;
               collection;&#xD;
  &#xD;
            -  History of urinary tract tumour;&#xD;
  &#xD;
            -  History of histologically proven interstitial cystitis;&#xD;
  &#xD;
            -  Persons under legal protection (safeguard of justice, curatorship, guardianship);&#xD;
  &#xD;
            -  Persons deprived of their liberty.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>LOÏC JACOB</last_name>
      <phone>0299282555</phone>
      <email>loic.jacob@chu-rennes.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rennes University Hospital</name>
        <address>
          <city>Rennes cedex 9</city>
          <state>CHU De Rennes</state>
          <zip>35033</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Camille Haudebert, MD</last_name>
        <email>Camille.HAUDEBERT@chu-rennes.fr</email>
      </contact>
      <contact_backup>
        <last_name>Benoit Peyronnet, MD</last_name>
        <email>Benoit.PEYRONNET@chu-rennes.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Benoit Peyronnet, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Spina Bifida</keyword>
    <keyword>urinary biomarker</keyword>
    <keyword>upper urinary tract</keyword>
    <keyword>Galloway score</keyword>
    <keyword>urodynamic work-up</keyword>
    <keyword>urethrocystography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Dysraphism</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/NCT06041334
  org study id: 35RC20_9746_SPINLESS
  secondary id: IDRCB
  nct id: NCT06041334
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate known urinary biomarkers in order to determine whether
        they can be predictive of a risk of damage to the upper urinary tract and therefore the
        kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be
        calculated using the Galloway score, based on the results of the urodynamic study and
        retrograde urethrocystography, which all patients with spina bifida have regularly.
  
        The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2
        (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has
        not yet been demonstrated.
  
        Volunteers to take part in the study will have their biomarkers measured at the time of their
        urodynamic assessment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: We will measure levels of the urinary biomarkers TIMP-2 and MMP-2 and we will report them to explain the Galloway score at the same time.
  time frame: 1 day
  description: We will use logistic regression, with the variable to be explained being the Galloway score ≤ 5 or > 5 (a qualitative variable with 2 classes) and the rate of urinary biomarkers as the explanatory variable
  arm group label: Study volunteers
  arm group type: Other
  intervention type: Biological
  intervention name: Collection of a urine sample
  description: Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
  arm group label: Study volunteers
  intervention type: Diagnostic Test
  intervention name: Magnetic Resonance Imaging of the bladder
  description: Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
  arm group label: Study volunteers
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: N/A
  healthy volunteers: No
  last name: LOÏC JACOB
  phone: 0299282555
  email: loic.jacob@chu-rennes.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Spinal Dysraphism