<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/NCT03833037</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-SAR-2018-100</org_study_id>
    <nct_id>NCT03833037</nct_id>
  </id_info>
  <brief_title>Study of a Cohort of Cases of Synovial Sarcoma Treated in the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between 1983 and 2016</brief_title>
  <official_title>Observational, Descriptive and Retrospective Study of a Cohort of 90 Consecutive Cases of Synovial Sarcoma Treated in the Orthopedic Surgery Unit of the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between the Years 1983 and 2016 ( 35 Years)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
      The main objectives of this study are the following: to describe the prognostic factors of&#xD;
      survival of synovial sarcoma in patients treated by the orthopedic surgery unit oncologic of&#xD;
      the orthopedic surgery and traumatology service of the Hospital de Sant Pau during the years&#xD;
      1983-2016.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Another objectives of this Study are:&#xD;
&#xD;
      To analyze exhaustively a series of cases of synovial sarcoma (as an example of classic&#xD;
      subtype of soft tissue sarcoma) to analyse the complementary tests performed and their&#xD;
      evolution over time.&#xD;
&#xD;
      To analyse the results of surgical treatment and adjuvant therapies in synovial sarcoma and&#xD;
      its evolution over time.&#xD;
&#xD;
      To study the prognostic factors dependent on the patient and the applied therapeutics.&#xD;
&#xD;
      To establish a results-based treatment and follow-up algorithm for patients diagnosed with&#xD;
      synovial sarcoma.&#xD;
&#xD;
      To describe the epidemiological characteristics of the group of patients in the study.&#xD;
&#xD;
      To evaluate the overall survival and disease-free survival as well as the mortality of the&#xD;
      disease.&#xD;
&#xD;
      To assess the rate of local recurrence and remote dissemination of synovial sarcomas in the&#xD;
      series.&#xD;
&#xD;
      To demonstrate the influence of neoadjuvant chemotherapy and radiotherapy in the treatment of&#xD;
      the tumor.&#xD;
&#xD;
      Conduct a study by age group with respect to the influence on patient survival. To carry out&#xD;
      a study by tumor-sized groups with respect to the influence on the survival of the patients.&#xD;
&#xD;
      To carry out a chronological study on the influence of the advances in the treatments on the&#xD;
      survival of the patients.&#xD;
&#xD;
      Compare the results obtained with the published literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Other</time_perspective>
  </study_design_info>
  <target_duration>23 Years</target_duration>
  <primary_outcome>
    <measure>Number of cases of synovial sarcoma</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Soft Tissue Sarcoma Adult</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soft tissue sarcomas in adults</intervention_name>
    <description>Adult sinovial sarcoma</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The overall sample size will be 90 cases of synovial sarcoma diagnosed and treated by the&#xD;
        unit, considering a sufficient number of cases in the analysis with sufficient potency to&#xD;
        respond to the issues raised methodology. Sources of information all clinical records of&#xD;
        the patients will be reviewed and a total of 104 elements collected, collecting data in&#xD;
        relation to the epidemiology, personal and family history, physical examination,&#xD;
        complementary tests of Local and extension diagnosis, time to diagnosis and treatment,&#xD;
        pathological diagnosis, surgical technique, adjuvant therapy, complications of treatment,&#xD;
        staging, clinical evolution, recurrences and metastases, functional valuation and data of&#xD;
        survival and follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The inclusion criteria were: diagnosed cases of synovial sarcoma by the service of&#xD;
        pathological anatomy and treated by unit orthopedic surgery oncology, in location of limbs,&#xD;
        paravertebral trunk and/or pelvis. We studied the complete medical history of the cases&#xD;
        available for the analysis and with a minimum follow-up of 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Lamas</last_name>
    <role>Study Director</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Synovial sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Sarcoma, Synovial</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/NCT03833037
org study id: IIBSP-SAR-2018-100
nct id: NCT03833037
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objectives of this study are the following: to describe the prognostic factors of
      survival of synovial sarcoma in patients treated by the orthopedic surgery unit oncologic of
      the orthopedic surgery and traumatology service of the Hospital de Sant Pau during the years
      1983-2016.
Another objectives of this Study are:

      To analyze exhaustively a series of cases of synovial sarcoma (as an example of classic
      subtype of soft tissue sarcoma) to analyse the complementary tests performed and their
      evolution over time.

      To analyse the results of surgical treatment and adjuvant therapies in synovial sarcoma and
      its evolution over time.

      To study the prognostic factors dependent on the patient and the applied therapeutics.

      To establish a results-based treatment and follow-up algorithm for patients diagnosed with
      synovial sarcoma.

      To describe the epidemiological characteristics of the group of patients in the study.

      To evaluate the overall survival and disease-free survival as well as the mortality of the
      disease.

      To assess the rate of local recurrence and remote dissemination of synovial sarcomas in the
      series.

      To demonstrate the influence of neoadjuvant chemotherapy and radiotherapy in the treatment of
      the tumor.

      Conduct a study by age group with respect to the influence on patient survival. To carry out
      a study by tumor-sized groups with respect to the influence on the survival of the patients.

      To carry out a chronological study on the influence of the advances in the treatments on the
      survival of the patients.

      Compare the results obtained with the published literature.
observational model: Cohort
time perspective: Other
measure: Number of cases of synovial sarcoma
time frame: Two years
intervention type: Other
intervention name: Soft tissue sarcomas in adults
description: Adult sinovial sarcoma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 100 Years
healthy volunteers: No
last name: Claudia Lamas
role: Study Director
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Sarcoma, Synovial
sharing ipd: Undecided