<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/NCT03776942</url>
  </required_header>
  <id_info>
    <org_study_id>SynoChondroS</org_study_id>
    <nct_id>NCT03776942</nct_id>
  </id_info>
  <brief_title>Synovial Chondrosarcoma: a Single Institution Experience</brief_title>
  <official_title>Synovial Chondrosarcoma: a Single Institution 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, radiological and clinical data&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      single institution cases series review of histological, radiological and clinical data.&#xD;
      Investigators will retrieve from the archives of the Rizzoli institute all the cases with a&#xD;
      histological diagnosis of synovial chondrosarcoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>selection and review of cases of Synovial Chondrosarcoma</measure>
    <time_frame>baseline (Day0)</time_frame>
    <description>IDH1 and IDH2 analysis will be performed in order to better understand tumor characteristics and to identify the best therapeutic approach.</description>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Synovial Chondrosarcoma</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tumor samples will be analysed by Dr. Dei Tos&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and Female ≥ 18 years with diagnosis of synovial chondrosarcoma with histological&#xD;
        slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to&#xD;
        perform the histology analysis&#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 January 1982 to 31&#xD;
             December 2017&#xD;
&#xD;
          -  Diagnosis of synovial chondrosarcoma&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Histological slides / formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from&#xD;
             archive available to perform the histology analysis&#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 synovial chondrosarcoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>IRCC Rizzoli Orthopedic Institute</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Ng VY, Louie P, Punt S, Conrad EU. Malignant Transformation of Synovial Chondromatosis: A Systematic Review. Open Orthop J. 2017 May 31;11:517-524. doi: 10.2174/1874325001711010517. eCollection 2017.</citation>
    <PMID>28694891</PMID>
  </results_reference>
  <results_reference>
    <citation>Biazzo A, Confalonieri N. Synovial chondrosarcoma. Ann Transl Med. 2016 Aug;4(15):280. doi: 10.21037/atm.2016.06.23.</citation>
    <PMID>27570774</PMID>
  </results_reference>
  <results_reference>
    <citation>Zamora EE, Mansor A, Vanel D, Errani C, Mercuri M, Picci P, Alberghini M. Synovial chondrosarcoma: report of two cases and literature review. Eur J Radiol. 2009 Oct;72(1):38-43. doi: 10.1016/j.ejrad.2009.05.029. Epub 2009 Jun 11.</citation>
    <PMID>19523777</PMID>
  </results_reference>
  <results_reference>
    <citation>Campanacci DA, Matera D, Franchi A, Capanna R. Synovial chondrosarcoma of the hip: report of two cases and literature review. Chir Organi Mov. 2008 Dec;92(3):139-44. doi: 10.1007/s12306-008-0062-3. Epub 2008 Dec 4.</citation>
    <PMID>19057985</PMID>
  </results_reference>
  <results_reference>
    <citation>Bertoni F, Unni KK, Beabout JW, Sim FH. Chondrosarcomas of the synovium. Cancer. 1991 Jan 1;67(1):155-62. doi: 10.1002/1097-0142(19910101)67:13.0.co;2-w.</citation>
    <PMID>1985712</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</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>Chondrosarcoma</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>May 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03776942/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/NCT03776942
org study id: SynoChondroS
nct id: NCT03776942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
single institution cases series review of histological, radiological and clinical data
single institution cases series review of histological, radiological and clinical data.
      Investigators will retrieve from the archives of the Rizzoli institute all the cases with a
      histological diagnosis of synovial chondrosarcoma.
observational model: Case-Only
time perspective: Retrospective
measure: selection and review of cases of Synovial Chondrosarcoma
time frame: baseline (Day0)
description: IDH1 and IDH2 analysis will be performed in order to better understand tumor characteristics and to identify the best therapeutic approach.
tumor samples will be analysed by Dr. Dei Tos
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Italy
citation: Ng VY, Louie P, Punt S, Conrad EU. Malignant Transformation of Synovial Chondromatosis: A Systematic Review. Open Orthop J. 2017 May 31;11:517-524. doi: 10.2174/1874325001711010517. eCollection 2017.
PMID: 28694891
citation: Biazzo A, Confalonieri N. Synovial chondrosarcoma. Ann Transl Med. 2016 Aug;4(15):280. doi: 10.21037/atm.2016.06.23.
PMID: 27570774
citation: Zamora EE, Mansor A, Vanel D, Errani C, Mercuri M, Picci P, Alberghini M. Synovial chondrosarcoma: report of two cases and literature review. Eur J Radiol. 2009 Oct;72(1):38-43. doi: 10.1016/j.ejrad.2009.05.029. Epub 2009 Jun 11.
PMID: 19523777
citation: Campanacci DA, Matera D, Franchi A, Capanna R. Synovial chondrosarcoma of the hip: report of two cases and literature review. Chir Organi Mov. 2008 Dec;92(3):139-44. doi: 10.1007/s12306-008-0062-3. Epub 2008 Dec 4.
PMID: 19057985
citation: Bertoni F, Unni KK, Beabout JW, Sim FH. Chondrosarcomas of the synovium. Cancer. 1991 Jan 1;67(1):155-62. doi: 10.1002/1097-0142(19910101)67:13.0.co;2-w.
PMID: 1985712
responsible party type: Sponsor
mesh term: Chondrosarcoma
provided document: 