<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/NCT03839095</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_Os_Pred_Mod</org_study_id>
    <nct_id>NCT03839095</nct_id>
  </id_info>
  <brief_title>Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model</brief_title>
  <official_title>Localized Osteosarcoma of Extremities: Developing a Clinical Prediction Model From a Country With Limited Resources</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <brief_summary>
    <textblock>
      To assess survival outcome of pediatric patients with localized osteosarcoma of the&#xD;
      extremities in Upper Egypt, identify factors of prognostic significance for survival, and to&#xD;
      determine factors predictive of surgical methods employed in these patients, and developing a&#xD;
      clinical model for risk prediction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting&#xD;
      for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a&#xD;
      peak incidence in the second decade of life.&#xD;
&#xD;
      In Upper Egypt, we have a higher proportion of the population in underdeveloped communities&#xD;
      with limited access to medical care so the patients usually seek medical advice at advanced&#xD;
      stage leading to a higher prevalence of metastatic disease at initial presentation, as well&#xD;
      as a greater proportion of larger tumor size that more likely to be associated with potential&#xD;
      adverse risk criteria prior to surgery.&#xD;
&#xD;
      A previous study from Upper Egypt showed that a metastatic disease at diagnosis was&#xD;
      independently correlated to a dismal outcome. Since the effect of many other factors of&#xD;
      prognostic significance, such as, gender, age, tumor location and response to chemotherapy&#xD;
      may have been mitigated by the large effect of the metastatic disease on the prognosis; So,&#xD;
      here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the&#xD;
      extremities, to determine prognostic factors associated with survival, and also to develop a&#xD;
      model for a better prediction of factors correlated to that a certain surgical approach was&#xD;
      employed in these patients based on their baseline clinical data and the tumor response to&#xD;
      chemotherapy.&#xD;
&#xD;
      Patients &amp; Methods We will carry out a retrospective analysis of data assembled from medical&#xD;
      records of 30 pediatric patients with a histologically-verified non-metastatic osteosarcoma&#xD;
      of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy&#xD;
      protocol between January 2001 and December 2015. These data will be categorized according to&#xD;
      demographic data, clinical characteristics, tumor response to chemotherapy, and surgical&#xD;
      methods employed in these patients. Prognostic factors will be determined using univariable&#xD;
      and multivariable methods. A predictive model for surgical outcomes in these patients based&#xD;
      on the baseline clinical factors, and their tumor response to chemotherapy will be developed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">August 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 20, 2018</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>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months</time_frame>
    <description>Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metastasis-Free survival (MFS)</measure>
    <time_frame>From date of treatment initiation until the date of first documented systemic recurrence or patients censored at last follow up, whichever came first, assessed up to 60 months</time_frame>
    <description>Participants will be retrospectively followed forward in time from the date of initiation of treatment till the occurrence of systemic recurrence, an expected average of 5 years</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Bone Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        30 pediatric patients with a histologically-verified non-metastatic osteosarcoma of the&#xD;
        extremities treated at South Egypt Cancer Institute with a unified chemotherapy protocol&#xD;
        between January 2001 and December 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose age less than 19 years.&#xD;
&#xD;
          -  Patients diagnosed with verified osteosarcoma involving the extremities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose age more than 19 years.&#xD;
&#xD;
          -  Non-extremities Osteosarcoma .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Morsy AM, Abdelgawad MI, Ahmed BM, Rezk KM, Aboelgheit AM, Ramadan IK, Kamel HEM, Fouad DM, Herdan RA, Shabaan SH, Eltyb HA. Pediatric Osteosarcoma of Extremities: A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt. J Pediatr Hematol Oncol. 2019 Aug;41(6):e371-e383. doi: 10.1097/MPH.0000000000001407.</citation>
    <PMID>30629005</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohammed Morsy, MD</investigator_full_name>
    <investigator_title>Lecturer, Pediatric Oncology Department</investigator_title>
  </responsible_party>
  <keyword>Nonmetastatic Osteosarcoma</keyword>
  <keyword>Pediatric Cancer</keyword>
  <keyword>Limb Salvage</keyword>
  <keyword>Prediction Model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteosarcoma</mesh_term>
    <mesh_term>Bone 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/NCT03839095
org study id: IRB_Os_Pred_Mod
nct id: NCT03839095
lead sponsor: 
To assess survival outcome of pediatric patients with localized osteosarcoma of the
      extremities in Upper Egypt, identify factors of prognostic significance for survival, and to
      determine factors predictive of surgical methods employed in these patients, and developing a
      clinical model for risk prediction.
Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting
      for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a
      peak incidence in the second decade of life.

      In Upper Egypt, we have a higher proportion of the population in underdeveloped communities
      with limited access to medical care so the patients usually seek medical advice at advanced
      stage leading to a higher prevalence of metastatic disease at initial presentation, as well
      as a greater proportion of larger tumor size that more likely to be associated with potential
      adverse risk criteria prior to surgery.

      A previous study from Upper Egypt showed that a metastatic disease at diagnosis was
      independently correlated to a dismal outcome. Since the effect of many other factors of
      prognostic significance, such as, gender, age, tumor location and response to chemotherapy
      may have been mitigated by the large effect of the metastatic disease on the prognosis; So,
      here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the
      extremities, to determine prognostic factors associated with survival, and also to develop a
      model for a better prediction of factors correlated to that a certain surgical approach was
      employed in these patients based on their baseline clinical data and the tumor response to
      chemotherapy.

      Patients & Methods We will carry out a retrospective analysis of data assembled from medical
      records of 30 pediatric patients with a histologically-verified non-metastatic osteosarcoma
      of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy
      protocol between January 2001 and December 2015. These data will be categorized according to
      demographic data, clinical characteristics, tumor response to chemotherapy, and surgical
      methods employed in these patients. Prognostic factors will be determined using univariable
      and multivariable methods. A predictive model for surgical outcomes in these patients based
      on the baseline clinical factors, and their tumor response to chemotherapy will be developed.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival (OS)
time frame: From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
description: Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years
measure: Metastasis-Free survival (MFS)
time frame: From date of treatment initiation until the date of first documented systemic recurrence or patients censored at last follow up, whichever came first, assessed up to 60 months
description: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the occurrence of systemic recurrence, an expected average of 5 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 19 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Morsy AM, Abdelgawad MI, Ahmed BM, Rezk KM, Aboelgheit AM, Ramadan IK, Kamel HEM, Fouad DM, Herdan RA, Shabaan SH, Eltyb HA. Pediatric Osteosarcoma of Extremities: A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt. J Pediatr Hematol Oncol. 2019 Aug;41(6):e371-e383. doi: 10.1097/MPH.0000000000001407.
PMID: 30629005
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohammed Morsy, MD
investigator title: Lecturer, Pediatric Oncology Department
mesh term: Osteosarcoma
mesh term: Bone Neoplasms