<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/NCT03764930</url>
  </required_header>
  <id_info>
    <org_study_id>yanghs201812</org_study_id>
    <nct_id>NCT03764930</nct_id>
  </id_info>
  <brief_title>Attention to Retinoblastoma Diagnosed in the Trauma Setting</brief_title>
  <official_title>Attention to Retinoblastoma Diagnosed in the Trauma Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the clinical characteristics and treatment outcomes of patients who experienced&#xD;
      inadvertent trauma before diagnosis of retinoblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective study of the clinical characteristics and treatment outcomes of patients who&#xD;
      experienced inadvertent trauma before diagnosis of retinoblastoma and to alert&#xD;
      ophthalmologists to the possibility of RB in children presenting with or without&#xD;
      trauma-related symptoms and signs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival Status</measure>
    <time_frame>between January 2013 and August 2018</time_frame>
    <description>Outcome at last follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trauma incidence of RB patients</measure>
    <time_frame>between January 2013 and August 2018</time_frame>
    <description>We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of trauma among RB patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RB incidence of pre-school patients with trauma history</measure>
    <time_frame>between January 2013 and August 2018</time_frame>
    <description>We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of RB among pre-school patients with trauma history.</description>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Retinoblastoma</condition>
  <condition>Wounds and Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unsuspected Retinoblastoma</intervention_name>
    <description>To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those children who experienced accidental ocular trauma with or without brain involvement&#xD;
        before diagnosis of unsuspected RB was studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The consecutive patients with RB managed at the ocular oncology service of Zhongshan&#xD;
             Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who didn't have undergone trauma before diagnosis of RB.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Huasheng Yang, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Huasheng Yang</investigator_full_name>
    <investigator_title>Head of Orbital Diseases and Ocular Oncology, Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinoblastoma</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03764930
org study id: yanghs201812
nct id: NCT03764930
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To study the clinical characteristics and treatment outcomes of patients who experienced
      inadvertent trauma before diagnosis of retinoblastoma.
Retrospective study of the clinical characteristics and treatment outcomes of patients who
      experienced inadvertent trauma before diagnosis of retinoblastoma and to alert
      ophthalmologists to the possibility of RB in children presenting with or without
      trauma-related symptoms and signs.
observational model: Case-Only
time perspective: Retrospective
measure: Survival Status
time frame: between January 2013 and August 2018
description: Outcome at last follow-up
measure: Trauma incidence of RB patients
time frame: between January 2013 and August 2018
description: We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of trauma among RB patients.
measure: RB incidence of pre-school patients with trauma history
time frame: between January 2013 and August 2018
description: We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of RB among pre-school patients with trauma history.
intervention type: Other
intervention name: Unsuspected Retinoblastoma
description: To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 80 Years
last name: Huasheng Yang, MD,PhD
role: Study Director
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Huasheng Yang
investigator title: Head of Orbital Diseases and Ocular Oncology, Clinical Professor
mesh term: Retinoblastoma
mesh term: Wounds and Injuries
sharing ipd: Undecided