<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/NCT02996734</url>
  </required_header>
  <id_info>
    <org_study_id>0008286</org_study_id>
    <nct_id>NCT02996734</nct_id>
  </id_info>
  <brief_title>Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment</brief_title>
  <acronym>GCTLIMBS</acronym>
  <official_title>Il Tumore a Cellule Giganti Delle estermità</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 present the outcomes of patients with giant cell tumor of&#xD;
      bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators retrospectively review patients treated for GCTB of the extremities between&#xD;
      1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after&#xD;
      surgical and medical treatment of patients with GCTB of the extremities to determine the&#xD;
      influence of the surgical approach, denosumab therapy, local tumor presentation, and&#xD;
      demographic factors on the risk of recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 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 after surgical and medical treatment</measure>
    <time_frame>within the first 36 months after surgery</time_frame>
  </primary_outcome>
  <enrollment type="Actual">412</enrollment>
  <condition>Giant Cell Tumor of Bone</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>curettage and resection</intervention_name>
    <description>the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration</description>
    <other_name>denosumab</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with giant cell tumor of bone treated in a single institution&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  giant cell tumors of the extremities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  giant cell tumors of the 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>giant cell tumor</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Giant Cell Tumors</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Giant Cell Tumor of Bone</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Denosumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>publish a manuscript 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/NCT02996734
org study id: 0008286
nct id: NCT02996734
lead sponsor: 
has dmc: No
The purpose of this project is to present the outcomes of patients with giant cell tumor of
      bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.
The investigators retrospectively review patients treated for GCTB of the extremities between
      1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after
      surgical and medical treatment of patients with GCTB of the extremities to determine the
      influence of the surgical approach, denosumab therapy, local tumor presentation, and
      demographic factors on the risk of recurrence.
observational model: Case-Only
time perspective: Retrospective
measure: local recurrence rate after surgical and medical treatment
time frame: within the first 36 months after surgery
intervention type: Procedure
intervention name: curettage and resection
description: the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration
other name: denosumab
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: Giant Cell Tumors
mesh term: Bone Neoplasms
mesh term: Giant Cell Tumor of Bone
mesh term: Denosumab
sharing ipd: Yes
ipd description: publish a manuscript in international medical journal