<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/NCT03768076</url>
  </required_header>
  <id_info>
    <org_study_id>POsT</org_study_id>
    <nct_id>NCT03768076</nct_id>
  </id_info>
  <brief_title>an Istitution Experience on Parosteal OsTeosarcoma</brief_title>
  <official_title>Parosteal OsTeosarcoma: a Single Istitution Experience</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>
      single institution cases series review of histological and clinical data&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma&#xD;
      treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 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>retrospective analysis of cases of Parosteal osteosarcoma</measure>
    <time_frame>at baseline (Day0)</time_frame>
    <description>Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.</description>
  </primary_outcome>
  <enrollment type="Actual">220</enrollment>
  <condition>Parosteal Osteosarcoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        male and female with diagnosis of parosteal osteosarcoma treated at Rizzoli institute from&#xD;
        01 Jan 1900 to 31 Jul 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018&#xD;
&#xD;
          -  Diagnosis of parosteal osteosarcoma&#xD;
&#xD;
          -  Written informed consent prior to any study-specific analysis and/or data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with histological diagnosis different from parosteal osteosarcoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Istituto ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg Oncol. 2008 Feb 1;97(2):146-9. doi: 10.1002/jso.20902.</citation>
    <PMID>18050289</PMID>
  </results_reference>
  <results_reference>
    <citation>Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. doi: 10.1002/cncr.21039.</citation>
    <PMID>15852358</PMID>
  </results_reference>
  <results_reference>
    <citation>Okada K, Frassica FJ, Sim FH, Beabout JW, Bond JR, Unni KK. Parosteal osteosarcoma. A clinicopathological study. J Bone Joint Surg Am. 1994 Mar;76(3):366-78. doi: 10.2106/00004623-199403000-00007.</citation>
    <PMID>8126042</PMID>
  </results_reference>
  <results_reference>
    <citation>Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone Joint J. 2015 Dec;97-B(12):1698-703. doi: 10.1302/0301-620X.97B12.35749.</citation>
    <PMID>26637687</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</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>
    <mesh_term>Osteosarcoma, Juxtacortical</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No Individual Patient Data sharing plan has been implemented</ipd_description>
  </patient_data>
  <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>September 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03768076/Prot_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/NCT03768076
org study id: POsT
nct id: NCT03768076
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
single institution cases series review of histological and clinical data
Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma
      treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.
observational model: Case-Only
time perspective: Retrospective
measure: retrospective analysis of cases of Parosteal osteosarcoma
time frame: at baseline (Day0)
description: Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
citation: Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg Oncol. 2008 Feb 1;97(2):146-9. doi: 10.1002/jso.20902.
PMID: 18050289
citation: Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. doi: 10.1002/cncr.21039.
PMID: 15852358
citation: Okada K, Frassica FJ, Sim FH, Beabout JW, Bond JR, Unni KK. Parosteal osteosarcoma. A clinicopathological study. J Bone Joint Surg Am. 1994 Mar;76(3):366-78. doi: 10.2106/00004623-199403000-00007.
PMID: 8126042
citation: Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone Joint J. 2015 Dec;97-B(12):1698-703. doi: 10.1302/0301-620X.97B12.35749.
PMID: 26637687
responsible party type: Sponsor
mesh term: Osteosarcoma
mesh term: Osteosarcoma, Juxtacortical
sharing ipd: No
ipd description: No Individual Patient Data sharing plan has been implemented
provided document: 