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/NCT06017518</url>
    </required_header>
    <id_info>
      <org_study_id>OSTEO LR</org_study_id>
      <nct_id>NCT06017518</nct_id>
    </id_info>
    <brief_title>An Observational Study of Local Relapse After High Grade Osteosarcoma</brief_title>
    <acronym>OSTEO LR</acronym>
    <official_title>An Observational Study of Local Relapse After High Grade Osteosarcoma</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        multicenter retrospective and prospective study in patients with high-grade osteosarcoma&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter retrospective and prospective study that will analyze all cases with of&#xD;
        diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases&#xD;
        referring to each participant site.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>post local relapse survival</measure>
      <time_frame>24 months follow up</time_frame>
      <description>the aim of the study is to analyse the factors influencing post local relapse survival</description>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Osteosarcoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who experienced local relapse as first event of recurrence after treatment for&#xD;
          localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who experienced LR as first event of recurrence after treatment for localized&#xD;
               high-grade osteosarcoma of bone, including cases with synchronous lung metastases&#xD;
  &#xD;
            -  Adequate patient compliance to follow-up visits&#xD;
  &#xD;
            -  Written informed consent prior to any study-specific analysis and/or data collection&#xD;
  &#xD;
            -  No age limits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cases of LR demonstrated after &gt; 3 months after metastatic disease&#xD;
  &#xD;
            -  Impossibility to ensure adequate compliance&#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_contact>
      <last_name>Emanuela Palmerini, MD</last_name>
      <phone>051/6366</phone>
      <phone_ext>668</phone_ext>
      <email>emanuela.palmerini@ior.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>IRCCS Istituto Ortopedico Rizzoli</name>
        <address>
          <city>Bologna</city>
          <state>BO</state>
          <zip>40136</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emanuela Palmerini, MD</last_name>
        <phone>051/6366</phone>
        <phone_ext>668</phone_ext>
        <email>emanuela.palmerini@ior.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliero-Universitaria Pisana</name>
        <address>
          <city>Pisa</city>
          <state>PI</state>
          <zip>56126</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luca Coccoli, MD</last_name>
        <email>l.coccoli@ao-pisa.toscana.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>Osteosarcoma</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>January 10, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT06017518/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06017518
  org study id: OSTEO LR
  nct id: NCT06017518
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  multicenter retrospective and prospective study in patients with high-grade osteosarcoma
  This is a multicenter retrospective and prospective study that will analyze all cases with of
        diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases
        referring to each participant site.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: post local relapse survival
  time frame: 24 months follow up
  description: the aim of the study is to analyse the factors influencing post local relapse survival
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Emanuela Palmerini, MD
  phone: 051/6366
  phone ext: 668
  email: emanuela.palmerini@ior.it
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Osteosarcoma
  provided document: 