<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/NCT02199938</url>
  </required_header>
  <id_info>
    <org_study_id>EK 10/2007 (5)</org_study_id>
    <nct_id>NCT02199938</nct_id>
  </id_info>
  <brief_title>Identification and Characterization of Molecular Markers in Musculoskeletal Tumors</brief_title>
  <official_title>Identification and Characterization of Molecular Markers in Musculoskeletal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balgrist University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to improve the understanding of molecular mechanisms in the&#xD;
      development and progression of musculoskeletal tumors. These tumors do have in general&#xD;
      unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or&#xD;
      chemotherapy) could not enhance the prognosis of these patients during the last ten to&#xD;
      fifteen years. Therefore the investigators chose a new way, as they try to identify markers&#xD;
      on a genetic level, who ideally act as a basis to develop new treatment options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To definitely asses such molecular markers in musculoskeletal tumors they have to be&#xD;
      identified in human patient samples with corresponding tumors, before molecular markers can&#xD;
      be validated in animal models. Just because these soft tissue and bone tumors are rare&#xD;
      (compared to breast and lung carcinomas), it is of great importance that samples from all&#xD;
      patients treated at Balgrist University Hospital are collected systematically und stored&#xD;
      correspondingly. Only like this valid statements can be done. Therefore the investigators&#xD;
      intent to collect tissue and blood samples from all patients who agree in participating in&#xD;
      the study. The samples will be taken during routine biopsies and operations. To compare tumor&#xD;
      tissue and healthy tissue it is also planed to take samples from tumor free patients who&#xD;
      undergo a knee replacement surgery. The investigators would store the surgical waste and&#xD;
      involve these samples in the analyzes.&#xD;
&#xD;
      Clinical data regarding diagnosis and examination findings, as well as tissue from biopsies&#xD;
      and surgeries will be collected prospectively. The tissue will be frozen in liquid nitrogen&#xD;
      according to standard procedures and stored until the molecular analyzes at the Laboratory of&#xD;
      Orthopedic Research at Balgrist University Hospital. The processing involves expression&#xD;
      analyzes such as polymerase chain reaction, Western Blot, micro arrays, immunohistochemistry&#xD;
      and tissue array. The DNA from the taken blood samples shall be compared with the DNA found&#xD;
      in the tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator has left the Institution&#xD;
  </why_stopped>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Tumor RNA in resected tissue</measure>
    <time_frame>at time of surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cell free tumor RNA in blood plasma</measure>
    <time_frame>7 to 1 day before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell free tumor RNA in blood plasma</measure>
    <time_frame>1 day after surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Soft Tissue and Bone Tumors</condition>
  <condition>Sarcoma</condition>
  <condition>Sarcoma of Bone</condition>
  <condition>Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>musculoskeletal tumors</arm_group_label>
    <description>Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identification and characterization of molecular markers in musculoskeletal tumors</intervention_name>
    <arm_group_label>musculoskeletal tumors</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood serum blood plasma tumor tissue tumor free tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who receive a biopsy or surgery because of confirmed or suspected&#xD;
        musculoskeletal tumor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery or biopsy of a bone- or soft tissue tumor&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients wish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>September 30, 2018</last_update_submitted>
  <last_update_submitted_qc>September 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</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>Sarcoma</mesh_term>
    <mesh_term>Neoplasms, Connective and Soft Tissue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02199938
org study id: EK 10/2007 (5)
nct id: NCT02199938
lead sponsor: 
has dmc: No
The aim of the study is to improve the understanding of molecular mechanisms in the
      development and progression of musculoskeletal tumors. These tumors do have in general
      unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or
      chemotherapy) could not enhance the prognosis of these patients during the last ten to
      fifteen years. Therefore the investigators chose a new way, as they try to identify markers
      on a genetic level, who ideally act as a basis to develop new treatment options.
To definitely asses such molecular markers in musculoskeletal tumors they have to be
      identified in human patient samples with corresponding tumors, before molecular markers can
      be validated in animal models. Just because these soft tissue and bone tumors are rare
      (compared to breast and lung carcinomas), it is of great importance that samples from all
      patients treated at Balgrist University Hospital are collected systematically und stored
      correspondingly. Only like this valid statements can be done. Therefore the investigators
      intent to collect tissue and blood samples from all patients who agree in participating in
      the study. The samples will be taken during routine biopsies and operations. To compare tumor
      tissue and healthy tissue it is also planed to take samples from tumor free patients who
      undergo a knee replacement surgery. The investigators would store the surgical waste and
      involve these samples in the analyzes.

      Clinical data regarding diagnosis and examination findings, as well as tissue from biopsies
      and surgeries will be collected prospectively. The tissue will be frozen in liquid nitrogen
      according to standard procedures and stored until the molecular analyzes at the Laboratory of
      Orthopedic Research at Balgrist University Hospital. The processing involves expression
      analyzes such as polymerase chain reaction, Western Blot, micro arrays, immunohistochemistry
      and tissue array. The DNA from the taken blood samples shall be compared with the DNA found
      in the tumor.
observational model: Cohort
time perspective: Prospective
measure: Tumor RNA in resected tissue
time frame: at time of surgery
measure: Cell free tumor RNA in blood plasma
time frame: 7 to 1 day before surgery
measure: Cell free tumor RNA in blood plasma
time frame: 1 day after surgery
arm group label: musculoskeletal tumors
description: Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery
intervention type: Other
intervention name: Identification and characterization of molecular markers in musculoskeletal tumors
arm group label: musculoskeletal tumors
blood serum blood plasma tumor tissue tumor free tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Neoplasms, Connective and Soft Tissue
sharing ipd: Undecided