<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/NCT04451304</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE 28598120.5.0000.5505</org_study_id>
    <nct_id>NCT04451304</nct_id>
  </id_info>
  <brief_title>Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma</brief_title>
  <official_title>Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective observational study in patients undergoing intra-arterial ophthalmic artery&#xD;
      chemotherapy for the treatment of retinoblastoma. The main objective of the study is to&#xD;
      evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to&#xD;
      investigate the association between autonomic reflexes and perioperative clinical&#xD;
      characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2021</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>1 Day</target_duration>
  <primary_outcome>
    <measure>Cardiorespiratory autonomic reflexes incidence</measure>
    <time_frame>from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)</time_frame>
    <description>To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical background and autonomic reflexes occurence</measure>
    <time_frame>from the admission of the patient in the operating room until the end of the procedure.</time_frame>
    <description>To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Retinoblastoma</condition>
  <condition>Retinoblastoma Bilateral</condition>
  <condition>Chemotherapy Effect</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children undergoing cancer treatment for unilateral or bilateral retinoblastoma at the&#xD;
        Instituto de Oncologia Pediátrica da Universidade Federal de São Paulo - GRAACC, São Paulo&#xD;
        - Brasil.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients diagnosed with retinoblastoma and submitted to intra-arterial&#xD;
             chemotherapy during the study period&#xD;
&#xD;
          -  Informed consent form signed and dated by legal guardian and investigator&#xD;
&#xD;
          -  Informed assent form signed by the patient if appropriate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient or guardian to participate in the research project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariana F Lima, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mariana F Lima, MD, PhD</last_name>
    <phone>+551150809236</phone>
    <email>marifonteslima@yahoo.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariana F Lima, MD</last_name>
      <phone>+551150809236</phone>
      <email>marifonteslima@yahoo.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Mariana Fontes Lima Neville</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Retinoblastoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinoblastoma</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/NCT04451304
org study id: CAAE 28598120.5.0000.5505
nct id: NCT04451304
lead sponsor: 
has dmc: No
Prospective observational study in patients undergoing intra-arterial ophthalmic artery
      chemotherapy for the treatment of retinoblastoma. The main objective of the study is to
      evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to
      investigate the association between autonomic reflexes and perioperative clinical
      characteristics.
observational model: Cohort
time perspective: Prospective
measure: Cardiorespiratory autonomic reflexes incidence
time frame: from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)
description: To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center.
measure: Clinical background and autonomic reflexes occurence
time frame: from the admission of the patient in the operating room until the end of the procedure.
description: To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Mariana F Lima, MD, PhD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
last name: Mariana F Lima, MD, PhD
phone: +551150809236
email: marifonteslima@yahoo.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Mariana Fontes Lima Neville
investigator title: Principal Investigator
mesh term: Retinoblastoma