<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/NCT02996747</url>
  </required_header>
  <id_info>
    <org_study_id>0016890</org_study_id>
    <nct_id>NCT02996747</nct_id>
  </id_info>
  <brief_title>Low Grade Chondrosarcoma Versus Enchondroma</brief_title>
  <acronym>CONDRO1</acronym>
  <official_title>Low Grade Chondrosarcoma Versus Enchondroma: Challenges in Diagnosis and Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to verify possible clinical and radiological findings with&#xD;
      regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In&#xD;
      addition, this study presents the outcome of patients with enchondroma and low grade&#xD;
      chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators retrospectively review the records of 65 patients with enchondroma and 37&#xD;
      patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and&#xD;
      2014 in a single Institution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Chondroma</condition>
  <condition>Chondrosarcoma</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>curettage (intralesional surgery)</intervention_name>
    <description>comparison of two different tumors treated by curettage</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chondroma or low grade chondrosarcoma of bone treated in a single Institution&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chondroma or low grade chondrosarcoma of long bones&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chondroma or low grade chondrosarcoma of spine and pelvis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davide Donati, MD</last_name>
    <role>Study Director</role>
    <affiliation>Istituto Ortopedico Rizzoli</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
    <investigator_full_name>Costantino Errani</investigator_full_name>
    <investigator_title>MD; PhD.</investigator_title>
  </responsible_party>
  <keyword>bone tumors</keyword>
  <keyword>chondroma</keyword>
  <keyword>chondrosarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chondrosarcoma</mesh_term>
    <mesh_term>Chondroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>publish a paper in international medical journal</ipd_description>
  </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/NCT02996747
org study id: 0016890
nct id: NCT02996747
lead sponsor: 
has dmc: No
The purpose of this project is to verify possible clinical and radiological findings with
      regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In
      addition, this study presents the outcome of patients with enchondroma and low grade
      chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).
The investigators retrospectively review the records of 65 patients with enchondroma and 37
      patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and
      2014 in a single Institution.
observational model: Case-Only
time perspective: Retrospective
measure: Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)
time frame: 36 months
intervention type: Procedure
intervention name: curettage (intralesional surgery)
description: comparison of two different tumors treated by curettage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Davide Donati, MD
role: Study Director
affiliation: Istituto Ortopedico Rizzoli
responsible party type: Principal Investigator
investigator affiliation: Istituto Ortopedico Rizzoli
investigator full name: Costantino Errani
investigator title: MD; PhD.
mesh term: Chondrosarcoma
mesh term: Chondroma
sharing ipd: Yes
ipd description: publish a paper in international medical journal