<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/NCT03759327</url>
  </required_header>
  <id_info>
    <org_study_id>AFH</org_study_id>
    <nct_id>NCT03759327</nct_id>
  </id_info>
  <brief_title>Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series</brief_title>
  <official_title>Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series</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>
      single institution cases series review of histological and clinical data Investigators will&#xD;
      retrieve from the archives of the Rizzoli Institute all the cases with a histological&#xD;
      diagnosis of Angiomatoid Fibrous Histiocytoma. In all cases with enough available material,&#xD;
      immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue&#xD;
      tumor material.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>selection and review of 9 cases of Angiomatoid Fibrous Histiocytoma</measure>
    <time_frame>at baseline (Day0)</time_frame>
    <description>investigators will review all the medical records, radiological imaging, and histological slides of all cases to identify the best therapeutic approach.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>analysis of EWS-CREB1 and EWS-ATF1 mutation and ALK expression on tissue tumor material</measure>
    <time_frame>at baseline (Day0)</time_frame>
    <description>In all cases immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue tumor material. EWS-CREB1 and EWS-ATF1 mutation and ALK expression will be analyzed with RT-PCR and/or FISH analysis.</description>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Angiomatoid Fibrous Histiocytoma</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      immunohistochemistry will be performed on FFPE material. EWS-CREB1 and EWS-ATF1 mutation and&#xD;
      ALK expression will be analyzed with RT-PCR and/or FISH analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and Female with diagnosis of Angiomatoid Fibrous Histiocytoma 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 2006 to 31&#xD;
             December 2017&#xD;
&#xD;
          -  Diagnosis of Angiomatoid Fibrous Histiocytoma&#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 Angiomatoid Fibrous Histiocytoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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>Antonescu CR, Dal Cin P, Nafa K, Teot LA, Surti U, Fletcher CD, Ladanyi M. EWSR1-CREB1 is the predominant gene fusion in angiomatoid fibrous histiocytoma. Genes Chromosomes Cancer. 2007 Dec;46(12):1051-60. doi: 10.1002/gcc.20491.</citation>
    <PMID>17724745</PMID>
  </results_reference>
  <results_reference>
    <citation>Bohman SL, Goldblum JR, Rubin BP, Tanas MR, Billings SD. Angiomatoid fibrous histiocytoma: an expansion of the clinical and histological spectrum. Pathology. 2014 Apr;46(3):199-204. doi: 10.1097/PAT.0000000000000073.</citation>
    <PMID>24614712</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen G, Folpe AL, Colby TV, Sittampalam K, Patey M, Chen MG, Chan JK. Angiomatoid fibrous histiocytoma: unusual sites and unusual morphology. Mod Pathol. 2011 Dec;24(12):1560-70. doi: 10.1038/modpathol.2011.126. Epub 2011 Aug 5.</citation>
    <PMID>21822206</PMID>
  </results_reference>
  <results_reference>
    <citation>Noujaim J, Jones RL, Swansbury J, Gonzalez D, Benson C, Judson I, Fisher C, Thway K. The spectrum of EWSR1-rearranged neoplasms at a tertiary sarcoma centre; assessing 772 tumour specimens and the value of current ancillary molecular diagnostic modalities. Br J Cancer. 2017 Feb 28;116(5):669-678. doi: 10.1038/bjc.2017.4. Epub 2017 Jan 31.</citation>
    <PMID>28141799</PMID>
  </results_reference>
  <results_reference>
    <citation>Rossi S, Szuhai K, Ijszenga M, Tanke HJ, Zanatta L, Sciot R, Fletcher CD, Dei Tos AP, Hogendoorn PC. EWSR1-CREB1 and EWSR1-ATF1 fusion genes in angiomatoid fibrous histiocytoma. Clin Cancer Res. 2007 Dec 15;13(24):7322-8. doi: 10.1158/1078-0432.CCR-07-1744.</citation>
    <PMID>18094413</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 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>Histiocytoma</mesh_term>
    <mesh_term>Histiocytoma, Benign Fibrous</mesh_term>
    <mesh_term>Histiocytoma, Malignant Fibrous</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 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03759327/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/NCT03759327
org study id: AFH
nct id: NCT03759327
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
single institution cases series review of histological and clinical data Investigators will
      retrieve from the archives of the Rizzoli Institute all the cases with a histological
      diagnosis of Angiomatoid Fibrous Histiocytoma. In all cases with enough available material,
      immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue
      tumor material.
observational model: Case-Only
time perspective: Other
measure: selection and review of 9 cases of Angiomatoid Fibrous Histiocytoma
time frame: at baseline (Day0)
description: investigators will review all the medical records, radiological imaging, and histological slides of all cases to identify the best therapeutic approach.
measure: analysis of EWS-CREB1 and EWS-ATF1 mutation and ALK expression on tissue tumor material
time frame: at baseline (Day0)
description: In all cases immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue tumor material. EWS-CREB1 and EWS-ATF1 mutation and ALK expression will be analyzed with RT-PCR and/or FISH analysis.
immunohistochemistry will be performed on FFPE material. EWS-CREB1 and EWS-ATF1 mutation and
      ALK expression will be analyzed with RT-PCR and/or FISH analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
citation: Antonescu CR, Dal Cin P, Nafa K, Teot LA, Surti U, Fletcher CD, Ladanyi M. EWSR1-CREB1 is the predominant gene fusion in angiomatoid fibrous histiocytoma. Genes Chromosomes Cancer. 2007 Dec;46(12):1051-60. doi: 10.1002/gcc.20491.
PMID: 17724745
citation: Bohman SL, Goldblum JR, Rubin BP, Tanas MR, Billings SD. Angiomatoid fibrous histiocytoma: an expansion of the clinical and histological spectrum. Pathology. 2014 Apr;46(3):199-204. doi: 10.1097/PAT.0000000000000073.
PMID: 24614712
citation: Chen G, Folpe AL, Colby TV, Sittampalam K, Patey M, Chen MG, Chan JK. Angiomatoid fibrous histiocytoma: unusual sites and unusual morphology. Mod Pathol. 2011 Dec;24(12):1560-70. doi: 10.1038/modpathol.2011.126. Epub 2011 Aug 5.
PMID: 21822206
citation: Noujaim J, Jones RL, Swansbury J, Gonzalez D, Benson C, Judson I, Fisher C, Thway K. The spectrum of EWSR1-rearranged neoplasms at a tertiary sarcoma centre; assessing 772 tumour specimens and the value of current ancillary molecular diagnostic modalities. Br J Cancer. 2017 Feb 28;116(5):669-678. doi: 10.1038/bjc.2017.4. Epub 2017 Jan 31.
PMID: 28141799
citation: Rossi S, Szuhai K, Ijszenga M, Tanke HJ, Zanatta L, Sciot R, Fletcher CD, Dei Tos AP, Hogendoorn PC. EWSR1-CREB1 and EWSR1-ATF1 fusion genes in angiomatoid fibrous histiocytoma. Clin Cancer Res. 2007 Dec 15;13(24):7322-8. doi: 10.1158/1078-0432.CCR-07-1744.
PMID: 18094413
responsible party type: Sponsor
mesh term: Histiocytoma
mesh term: Histiocytoma, Benign Fibrous
mesh term: Histiocytoma, Malignant Fibrous
sharing ipd: No
ipd description: No Individual Patient Data sharing plan has been implemented
provided document: 