<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/NCT04458792</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-BDD 2016/03</org_study_id>
    <nct_id>NCT04458792</nct_id>
  </id_info>
  <brief_title>Establishment of a Prospective Clinical-biological Database</brief_title>
  <acronym>BCBSarcome</acronym>
  <official_title>Development of a Monocentric and Prospective Clinical and Biological Database in Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</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>
      A Clinical and Biological Database will provide to the scientific community a collection of&#xD;
      blood and tissues with clinical data to improve knowledge about cancer and help to develope&#xD;
      new cancer treatments. This database is specific to Sarcoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liposarcomas (LPS) are soft tissue tumours of mesenchymal origin. The most common&#xD;
      histological subtypes, represented by well differenciated Lipsarcomas (WD-LPS) and&#xD;
      dedifferenciated (DD-LPS), are characterized by the quasi-systematic amplification of the&#xD;
      q13-15 of chromosome 12 containing the Mdm2 gene.&#xD;
&#xD;
      The systematic amplification of the Mdm2 gene is such that it is used clinically to&#xD;
      distinguish WD/DD-LPS from other types of sarcomas. These observations raise key questions&#xD;
      about the high selection pressure that leads to the almost systematic amplification of Mdm2&#xD;
      during the development of these LPS.&#xD;
&#xD;
      Mdm2 is an oncoprotein whose roles in p53 tumour suppressor degradation are broadly&#xD;
      described. However, the different inhibitors targeting this interaction were disappointing in&#xD;
      clinical trials.&#xD;
&#xD;
      Recently a team from the U1194 INSERM unit of the IRCM which collaborates in this project&#xD;
      showed by a pan-genomics analysis, that Mdm2 is recruited to chromatin within a multiproteic&#xD;
      complex having as target a transcriptional program involved in the metabolism and in&#xD;
      particular in the biosynthesis of the serin.&#xD;
&#xD;
      This clinical-biological basis will allow the continuation of this research project on&#xD;
      liposarcomas and the development of new research projects on other histological types of&#xD;
      sarcomas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">November 2027</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Establishment a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about sarcoma</measure>
    <time_frame>Until the study completion : 5 years</time_frame>
    <description>number of collection of tissue samples (tumour tissue and healthy tissue) in patients operated on a sarcoma associated with clinical data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establishment a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about sarcoma</measure>
    <time_frame>Until the study completion : 5 years</time_frame>
    <description>Number of collection of blood in patients operated on a sarcoma associated with clinical data.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Experimental: Biological collection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For all the patients include in the study :&#xD;
Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue)&#xD;
MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery&#xD;
circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery&#xD;
radiotherapy toxicity : Blood samples collected before the radiotherapy&#xD;
In parallel to this biological collection, standardized clinical data will be entered into a database</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paraffin tissue samples</intervention_name>
    <description>Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue</description>
    <arm_group_label>Experimental: Biological collection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery radiotherapy toxicity : Blood samples collected before the radiotherapy</description>
    <arm_group_label>Experimental: Biological collection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men or women &gt; 18 years&#xD;
&#xD;
          -  Patient treated by surgery for : a primitive sarcoma and/or local relapse sarcoma&#xD;
             and/or metastatic localisation of sarcoma&#xD;
&#xD;
          -  patient accepted blood sample&#xD;
&#xD;
          -  patient treated by radiotherapy before or after the surgery&#xD;
&#xD;
          -  Patient signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not affiliated to french Social Protection system&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Patient unable to understand or comply with study instructions or requirements for&#xD;
             psychological, family, social or geographical reasons&#xD;
&#xD;
          -  Pregnancy and/or feeding&#xD;
&#xD;
          -  Patient take care in an Emergency Situation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>FIRMIN Nelly, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BLEUSE Jean-Pierre, MD</last_name>
    <phone>4 67 61 31 00</phone>
    <phone_ext>+33</phone_ext>
    <email>DRCI-icm105@icm.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Ducimetiere F, Lurkin A, Ranchere-Vince D, Decouvelaere AV, Peoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.</citation>
    <PMID>21826194</PMID>
  </results_reference>
  <results_reference>
    <citation>Mastrangelo G, Coindre JM, Ducimetiere F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchere-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 European regions. Cancer. 2012 Nov 1;118(21):5339-48. doi: 10.1002/cncr.27555. Epub 2012 Apr 19.</citation>
    <PMID>22517534</PMID>
  </results_reference>
  <results_reference>
    <citation>Crago AM, Singer S. Clinical and molecular approaches to well differentiated and dedifferentiated liposarcoma. Curr Opin Oncol. 2011 Jul;23(4):373-8. doi: 10.1097/CCO.0b013e32834796e6.</citation>
    <PMID>21552124</PMID>
  </results_reference>
  <results_reference>
    <citation>Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Ruschoff J, Schildhaus HU. Challenging dedifferentiated liposarcoma identified by MDM2-amplification, a report of two cases. BMC Clin Pathol. 2014 Jul 28;14:36. doi: 10.1186/1472-6890-14-36. eCollection 2014.</citation>
    <PMID>25126005</PMID>
  </results_reference>
  <results_reference>
    <citation>Marine JC, Lozano G. Mdm2-mediated ubiquitylation: p53 and beyond. Cell Death Differ. 2010 Jan;17(1):93-102. doi: 10.1038/cdd.2009.68.</citation>
    <PMID>19498444</PMID>
  </results_reference>
  <results_reference>
    <citation>Ray-Coquard I, Blay JY, Italiano A, Le Cesne A, Penel N, Zhi J, Heil F, Rueger R, Graves B, Ding M, Geho D, Middleton SA, Vassilev LT, Nichols GL, Bui BN. Effect of the MDM2 antagonist RG7112 on the P53 pathway in patients with MDM2-amplified, well-differentiated or dedifferentiated liposarcoma: an exploratory proof-of-mechanism study. Lancet Oncol. 2012 Nov;13(11):1133-40. doi: 10.1016/S1470-2045(12)70474-6. Epub 2012 Oct 17.</citation>
    <PMID>23084521</PMID>
  </results_reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biological specimen banks</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04458792
org study id: ICM-BDD 2016/03
nct id: NCT04458792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Clinical and Biological Database will provide to the scientific community a collection of
      blood and tissues with clinical data to improve knowledge about cancer and help to develope
      new cancer treatments. This database is specific to Sarcoma
Liposarcomas (LPS) are soft tissue tumours of mesenchymal origin. The most common
      histological subtypes, represented by well differenciated Lipsarcomas (WD-LPS) and
      dedifferenciated (DD-LPS), are characterized by the quasi-systematic amplification of the
      q13-15 of chromosome 12 containing the Mdm2 gene.

      The systematic amplification of the Mdm2 gene is such that it is used clinically to
      distinguish WD/DD-LPS from other types of sarcomas. These observations raise key questions
      about the high selection pressure that leads to the almost systematic amplification of Mdm2
      during the development of these LPS.

      Mdm2 is an oncoprotein whose roles in p53 tumour suppressor degradation are broadly
      described. However, the different inhibitors targeting this interaction were disappointing in
      clinical trials.

      Recently a team from the U1194 INSERM unit of the IRCM which collaborates in this project
      showed by a pan-genomics analysis, that Mdm2 is recruited to chromatin within a multiproteic
      complex having as target a transcriptional program involved in the metabolism and in
      particular in the biosynthesis of the serin.

      This clinical-biological basis will allow the continuation of this research project on
      liposarcomas and the development of new research projects on other histological types of
      sarcomas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Establishment a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about sarcoma
time frame: Until the study completion : 5 years
description: number of collection of tissue samples (tumour tissue and healthy tissue) in patients operated on a sarcoma associated with clinical data.
measure: Establishment a clinical and biological database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about sarcoma
time frame: Until the study completion : 5 years
description: Number of collection of blood in patients operated on a sarcoma associated with clinical data.
arm group label: Experimental: Biological collection
arm group type: Experimental
description: For all the patients include in the study :
Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue)
MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery
circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery
radiotherapy toxicity : Blood samples collected before the radiotherapy
In parallel to this biological collection, standardized clinical data will be entered into a database
intervention type: Other
intervention name: Paraffin tissue samples
description: Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue
arm group label: Experimental: Biological collection
intervention type: Other
intervention name: blood sample
description: MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery radiotherapy toxicity : Blood samples collected before the radiotherapy
arm group label: Experimental: Biological collection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: FIRMIN Nelly, MD
role: Study Chair
affiliation: Institut régional du Cancer Montpellier
last name: BLEUSE Jean-Pierre, MD
phone: 4 67 61 31 00
phone ext: +33
email: DRCI-icm105@icm.unicancer.fr
facility: 
status: Recruiting
country: France
citation: Ducimetiere F, Lurkin A, Ranchere-Vince D, Decouvelaere AV, Peoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.
PMID: 21826194
citation: Mastrangelo G, Coindre JM, Ducimetiere F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchere-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 European regions. Cancer. 2012 Nov 1;118(21):5339-48. doi: 10.1002/cncr.27555. Epub 2012 Apr 19.
PMID: 22517534
citation: Crago AM, Singer S. Clinical and molecular approaches to well differentiated and dedifferentiated liposarcoma. Curr Opin Oncol. 2011 Jul;23(4):373-8. doi: 10.1097/CCO.0b013e32834796e6.
PMID: 21552124
citation: Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Ruschoff J, Schildhaus HU. Challenging dedifferentiated liposarcoma identified by MDM2-amplification, a report of two cases. BMC Clin Pathol. 2014 Jul 28;14:36. doi: 10.1186/1472-6890-14-36. eCollection 2014.
PMID: 25126005
citation: Marine JC, Lozano G. Mdm2-mediated ubiquitylation: p53 and beyond. Cell Death Differ. 2010 Jan;17(1):93-102. doi: 10.1038/cdd.2009.68.
PMID: 19498444
citation: Ray-Coquard I, Blay JY, Italiano A, Le Cesne A, Penel N, Zhi J, Heil F, Rueger R, Graves B, Ding M, Geho D, Middleton SA, Vassilev LT, Nichols GL, Bui BN. Effect of the MDM2 antagonist RG7112 on the P53 pathway in patients with MDM2-amplified, well-differentiated or dedifferentiated liposarcoma: an exploratory proof-of-mechanism study. Lancet Oncol. 2012 Nov;13(11):1133-40. doi: 10.1016/S1470-2045(12)70474-6. Epub 2012 Oct 17.
PMID: 23084521
responsible party type: Sponsor
mesh term: Sarcoma
sharing ipd: No