<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/NCT03839732</url>
  </required_header>
  <id_info>
    <org_study_id>CE AVEC 695/2018/Oss/IOR</org_study_id>
    <nct_id>NCT03839732</nct_id>
  </id_info>
  <brief_title>Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry</brief_title>
  <acronym>CALCIFY2D</acronym>
  <official_title>Calcify2D: Assessment of Observer Variability of a New Software for the Quantitative Evaluation of Abdominal Aortic Calcifications, Vertebral Morphometry and Their Relationships in Fragile Patients, Compared to Current Visual Scoring Methods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione C.N.R./Regione Toscana &quot;G. Monasterio&quot;, Pisa, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</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>
      BACKGROUND In the context of a progressively aging population, monitoring the status of&#xD;
      Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary&#xD;
      importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events&#xD;
      (hospitalization and/or death) and hip fractures respectively, and VF represent an&#xD;
      under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an&#xD;
      acknowledged relationships between VC and VF.&#xD;
&#xD;
      However, data about the emergence/progression of VC and the emergence/worsening of VF over&#xD;
      time are lacking. This is likely due to the absence of monitoring instruments for VC and VF&#xD;
      that are both precise and easily accessible/applicable.&#xD;
&#xD;
      OBJECTIVE This study aims to define the observer variability of a new software developed by&#xD;
      the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a&#xD;
      computer-assisted procedure to simultaneously score vascular calcifications at the abdominal&#xD;
      aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry&#xD;
      principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the&#xD;
      validation of the scores obtained from latero-lateral thoracolumbar spine radiography with&#xD;
      more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC,&#xD;
      Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on&#xD;
      the patients enrolled for the study.&#xD;
&#xD;
      STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic&#xD;
      images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR)&#xD;
      within a previous interventional study.&#xD;
&#xD;
      Scoring of VC and VF will be performed by four clinicians from four relevant specialties,&#xD;
      chosen among those who may often see VC and VF and are already familiar with the traditional&#xD;
      scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one&#xD;
      nephrologist from the National Research Council and one internist from University of Padua).&#xD;
&#xD;
      Each clinician will assess all radiographs to score VC and QVM, both via computer assisted&#xD;
      procedures and via traditional visual inspection. To avoid bias, an interval of at least one&#xD;
      week will be left between the computer assisted and visual scoring. To define intra-observer&#xD;
      variability (i.e. repeatability), the whole dataset will be re-assessed three times.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Observer variability in scoring Vascular Calcification at the abdominal aorta</measure>
    <time_frame>through study completion, 1 year at maximum</time_frame>
    <description>Observer variability (repeatability and reproducibility) in the assessment of vascular calcifications at the abdominal aorta according to a widely adopted scoring system (Kauppila et al., 1997): comparison between computer assisted and visual scoring.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observer variability in scoring Vertebral Fractures at the lumbar spine</measure>
    <time_frame>through study completion, 1 year at maximum</time_frame>
    <description>Observer variability (repeatability and reproducibility) in the assessment of vertebral fractures in the lumbar spine according to Quantitative Vertebral Morphometry (Genant et al., 2000): comparison between computer assisted and visual scoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of computer assisted VC score</measure>
    <time_frame>through study completion, 1 year at maximum</time_frame>
    <description>Accuracy of VC score computed by Calcify2D software will be tested against a gold standard CT-based score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of computer assisted QVM</measure>
    <time_frame>through study completion, 1 year at maximum</time_frame>
    <description>Accuracy of QVM score computed by Calcify2D software will be tested for the detection of mild vertebral fractures against gold standard Magnetic Resonance imaging</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Vascular Calcification</condition>
  <condition>Vertebral Fracture</condition>
  <arm_group>
    <arm_group_label>Vascular Calcification Group</arm_group_label>
    <description>Patients with prevalent vascular calcifications will be analysed to verify the intra- and inter-observer reliability of the score of abdominal aorta calcifications</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Score of abdominal aorta calcifications</intervention_name>
    <description>Radiographs showing VC will be used to assess whether the computer assisted VC scoring (primary objective) and Quantitative Vertebral Morphometry (QVM, limited to lumbar spine, secondary objective n.1) through the Calcify2D software are less variable with respect to the traditional visual scoring of VC and QVM.</description>
    <arm_group_label>Vascular Calcification Group</arm_group_label>
    <other_name>Score of lumbar spine vertebral fractures</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients that were included in a previous interventional trial of the sponsor&#xD;
        institution aimed to compare the effectiveness of vertebroplastic and kyphoplastic&#xD;
        augmentations of the throracolumbar spine. The choice of this population was driven by&#xD;
        previous reports on similar populations stating a high prevalence of vascular&#xD;
        calcifications.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included in a previous interventional study (VTP vs KYPHO) of the sponsor.&#xD;
&#xD;
          -  Availability of diagnostic images (Dorso-lumbar radiographies taken in L-L&#xD;
             projection).&#xD;
&#xD;
          -  Rx images will be screened for the presence of VC, retaining only those showing VC.&#xD;
&#xD;
          -  Informed consent obtained prior to any study analysis-evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Images showing severe artefacts (usually due to presence of metallic devices) that&#xD;
             alter the grayscale range and hinder correct identification of VC and vertebral&#xD;
             fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Enrico Schileo, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Ortopedico Rizzoli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>observer variability</keyword>
  <keyword>kauppila score</keyword>
  <keyword>quantitative vertebral morphometry</keyword>
  <keyword>computer assisted procedure</keyword>
  <keyword>abdominal aorta</keyword>
  <keyword>lumbar spine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcinosis</mesh_term>
    <mesh_term>Vascular Calcification</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03839732/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03839732
org study id: CE AVEC 695/2018/Oss/IOR
nct id: NCT03839732
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND In the context of a progressively aging population, monitoring the status of
      Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary
      importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events
      (hospitalization and/or death) and hip fractures respectively, and VF represent an
      under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an
      acknowledged relationships between VC and VF.

      However, data about the emergence/progression of VC and the emergence/worsening of VF over
      time are lacking. This is likely due to the absence of monitoring instruments for VC and VF
      that are both precise and easily accessible/applicable.

      OBJECTIVE This study aims to define the observer variability of a new software developed by
      the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a
      computer-assisted procedure to simultaneously score vascular calcifications at the abdominal
      aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry
      principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the
      validation of the scores obtained from latero-lateral thoracolumbar spine radiography with
      more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC,
      Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on
      the patients enrolled for the study.

      STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic
      images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR)
      within a previous interventional study.

      Scoring of VC and VF will be performed by four clinicians from four relevant specialties,
      chosen among those who may often see VC and VF and are already familiar with the traditional
      scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one
      nephrologist from the National Research Council and one internist from University of Padua).

      Each clinician will assess all radiographs to score VC and QVM, both via computer assisted
      procedures and via traditional visual inspection. To avoid bias, an interval of at least one
      week will be left between the computer assisted and visual scoring. To define intra-observer
      variability (i.e. repeatability), the whole dataset will be re-assessed three times.
observational model: Case-Only
time perspective: Retrospective
measure: Observer variability in scoring Vascular Calcification at the abdominal aorta
time frame: through study completion, 1 year at maximum
description: Observer variability (repeatability and reproducibility) in the assessment of vascular calcifications at the abdominal aorta according to a widely adopted scoring system (Kauppila et al., 1997): comparison between computer assisted and visual scoring.
measure: Observer variability in scoring Vertebral Fractures at the lumbar spine
time frame: through study completion, 1 year at maximum
description: Observer variability (repeatability and reproducibility) in the assessment of vertebral fractures in the lumbar spine according to Quantitative Vertebral Morphometry (Genant et al., 2000): comparison between computer assisted and visual scoring.
measure: Accuracy of computer assisted VC score
time frame: through study completion, 1 year at maximum
description: Accuracy of VC score computed by Calcify2D software will be tested against a gold standard CT-based score
measure: Accuracy of computer assisted QVM
time frame: through study completion, 1 year at maximum
description: Accuracy of QVM score computed by Calcify2D software will be tested for the detection of mild vertebral fractures against gold standard Magnetic Resonance imaging
arm group label: Vascular Calcification Group
description: Patients with prevalent vascular calcifications will be analysed to verify the intra- and inter-observer reliability of the score of abdominal aorta calcifications
intervention type: Diagnostic Test
intervention name: Score of abdominal aorta calcifications
description: Radiographs showing VC will be used to assess whether the computer assisted VC scoring (primary objective) and Quantitative Vertebral Morphometry (QVM, limited to lumbar spine, secondary objective n.1) through the Calcify2D software are less variable with respect to the traditional visual scoring of VC and QVM.
arm group label: Vascular Calcification Group
other name: Score of lumbar spine vertebral fractures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: Enrico Schileo, Ph.D.
role: Principal Investigator
affiliation: Istituto Ortopedico Rizzoli
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Calcinosis
mesh term: Vascular Calcification
mesh term: Spinal Fractures
sharing ipd: Undecided
provided document: 