<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/NCT01694654</url>
  </required_header>
  <id_info>
    <org_study_id>SFT-1</org_study_id>
    <nct_id>NCT01694654</nct_id>
  </id_info>
  <brief_title>Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura.</brief_title>
  <official_title>Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura. A Multicenter Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in&#xD;
           the German spoken part of Switzerland.&#xD;
&#xD;
        2. To define the role of immunohistochemical and molecular techniques, such as&#xD;
           immunostaining, FISH and mutational analysis regarding their ability to predict&#xD;
           malignant behavior in terms of prediction of overall survival and disease-free survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective observational study on patients with SFPT in the German spoken part of&#xD;
      Switzerland between 2000 and 2011 (approximately 300 patients):&#xD;
&#xD;
      Phase 1) Information leaflet (letter of invitation) from study center (University Hospital of&#xD;
      Zurich) to the institutes for pathology from all university, cantonal and city hospitals in&#xD;
      the German spoken part of Switzerland. Patient recruitment performed by medical staff from&#xD;
      the aforementioned institutes for pathology.&#xD;
&#xD;
      Phase 2) Obtaining first orally (by telephone) and thereafter written informed consent from&#xD;
      the patients performed by medical staff from the aforementioned institutes for pathology.&#xD;
&#xD;
      Phase 3) After written and oral consent has been given, a doctoral candidate (member of the&#xD;
      study group, student of the University of Zurich) will perform the data entry based on&#xD;
      clinical and histological records locally at each external institute for pathology (no&#xD;
      patient record files will be copied or transferred in original to the University Hospital of&#xD;
      Zurich). Data entry in the electronic case report from (excel file on study laptop) will be&#xD;
      performed with anonymous data only. Hence, each patient will have a study number containing&#xD;
      the treating hospital, year of diagnosis and a consecutive number (e.g. KSSG-2011-1,&#xD;
      KSSG-2011-2, STZ-2007-1, STZ-2007-2, …). No names or birth dates will appear in the case&#xD;
      report form.&#xD;
&#xD;
      Provided that informed consent is given, patient follow-up will be performed by contacting&#xD;
      the primary care physician (general physician or family doctor) by telephone, which is&#xD;
      handled by the doctoral candidate.&#xD;
&#xD;
      Deceased patients will not be incorporated within the study.&#xD;
&#xD;
      Phase 4) Review of the histological specimen which are collected by the aforementioned&#xD;
      doctoral candidate and brought to the University Hospital of Zurich, Institute for Pathology,&#xD;
      where immunohistochemical/molecular examinations, such as immunostaining, fluorescence in&#xD;
      situ hybridization (FISH) and mutational analysis of the histological specimen are performed&#xD;
      by PD Dr. A. Soltermann, member of the study team. After this, the specimens are returned to&#xD;
      the original institute for pathology, where they were taken. All specimens are made anonymous&#xD;
      at the moment of collection at the external hospital by the doctoral candidate (each specimen&#xD;
      is labeled with the aforementioned study number, which is assigned in the case report form).&#xD;
&#xD;
      Phase 5) Data analysis, publication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Solitary Fibrous Tumors of the Pleura</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor specimen (operative resectate)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Histologically proven diagnosis of SFTP between 2000 and 2011.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Histologically proven diagnosis of SFTP between 2000 and 2011.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Missing informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Divison of Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Internal Medicine</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</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>Solitary Fibrous Tumors</mesh_term>
    <mesh_term>Hemangiopericytoma</mesh_term>
    <mesh_term>Neoplasms, Fibrous Tissue</mesh_term>
    <mesh_term>Solitary Fibrous Tumor, Pleural</mesh_term>
    <mesh_term>Pleural Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01694654
org study id: SFT-1
nct id: NCT01694654
lead sponsor: 
has dmc: Yes
1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in
           the German spoken part of Switzerland.

        2. To define the role of immunohistochemical and molecular techniques, such as
           immunostaining, FISH and mutational analysis regarding their ability to predict
           malignant behavior in terms of prediction of overall survival and disease-free survival.
Retrospective observational study on patients with SFPT in the German spoken part of
      Switzerland between 2000 and 2011 (approximately 300 patients):

      Phase 1) Information leaflet (letter of invitation) from study center (University Hospital of
      Zurich) to the institutes for pathology from all university, cantonal and city hospitals in
      the German spoken part of Switzerland. Patient recruitment performed by medical staff from
      the aforementioned institutes for pathology.

      Phase 2) Obtaining first orally (by telephone) and thereafter written informed consent from
      the patients performed by medical staff from the aforementioned institutes for pathology.

      Phase 3) After written and oral consent has been given, a doctoral candidate (member of the
      study group, student of the University of Zurich) will perform the data entry based on
      clinical and histological records locally at each external institute for pathology (no
      patient record files will be copied or transferred in original to the University Hospital of
      Zurich). Data entry in the electronic case report from (excel file on study laptop) will be
      performed with anonymous data only. Hence, each patient will have a study number containing
      the treating hospital, year of diagnosis and a consecutive number (e.g. KSSG-2011-1,
      KSSG-2011-2, STZ-2007-1, STZ-2007-2, …). No names or birth dates will appear in the case
      report form.

      Provided that informed consent is given, patient follow-up will be performed by contacting
      the primary care physician (general physician or family doctor) by telephone, which is
      handled by the doctoral candidate.

      Deceased patients will not be incorporated within the study.

      Phase 4) Review of the histological specimen which are collected by the aforementioned
      doctoral candidate and brought to the University Hospital of Zurich, Institute for Pathology,
      where immunohistochemical/molecular examinations, such as immunostaining, fluorescence in
      situ hybridization (FISH) and mutational analysis of the histological specimen are performed
      by PD Dr. A. Soltermann, member of the study team. After this, the specimens are returned to
      the original institute for pathology, where they were taken. All specimens are made anonymous
      at the moment of collection at the external hospital by the doctoral candidate (each specimen
      is labeled with the aforementioned study number, which is assigned in the case report form).

      Phase 5) Data analysis, publication.
observational model: Cohort
time perspective: Retrospective
Tumor specimen (operative resectate)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Divison of Internal Medicine
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Solitary Fibrous Tumors
mesh term: Hemangiopericytoma
mesh term: Neoplasms, Fibrous Tissue
mesh term: Solitary Fibrous Tumor, Pleural
mesh term: Pleural Neoplasms