<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/NCT04425434</url>
  </required_header>
  <id_info>
    <org_study_id>GFAOP RB1</org_study_id>
    <nct_id>NCT04425434</nct_id>
  </id_info>
  <brief_title>Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma</brief_title>
  <acronym>GFARB12019</acronym>
  <official_title>Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Africa Pediatric Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Africa Pediatric Oncology Group</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>
      As the survival of children with retinoblastoma in high income countries is higher than 95%&#xD;
      including the bilateral forms this study hopes to improve the outcome in low income countries&#xD;
      in Africa by improving early diagnosis and early implementation of this protocol of&#xD;
      therapeutic recommendations for treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we will try to improve the outcome for children with stage II disease. It is&#xD;
      hoped that we will be able to show that with early intervention correct early diagnosis the&#xD;
      survival of these children is greatly improved. The collection of data in this observational&#xD;
      study will allow us to show this improvement, by analysis of stage, treatment and outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">October 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2028</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cases with retinoblastoma in each participating hospital.</measure>
    <time_frame>10 years</time_frame>
    <description>Evaluation of the number of cases registered .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases with stage 2 disease</measure>
    <time_frame>10 years</time_frame>
    <description>Evaluation of the number of cases registered with stage 2 disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of these therapeutic recommendations in an African setting</measure>
    <time_frame>10 years</time_frame>
    <description>Evaluate the application of these therapeutic recommendations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the treatment given.</measure>
    <time_frame>10 years</time_frame>
    <description>Comparison of treatment given and recommended treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>follow up</measure>
    <time_frame>10 years</time_frame>
    <description>analysis of the number of children alive or dead after treatment</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Retinoblastoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OBSERVATIONAL</intervention_name>
    <description>We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all children presenting at participating units who can be treated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral intraocular Retinoblastoma (RB)&#xD;
&#xD;
          -  Unilateral extraocular intraorbital (RB)&#xD;
&#xD;
          -  Bilateral intraocular (RB)&#xD;
&#xD;
          -  bilateral intraocular (RB) on one side and extraocular but intraorbital on the other&#xD;
             side.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Externalized tumor mass&#xD;
&#xD;
          -  massive extension to optic nerve up to optical channeltumor&#xD;
&#xD;
          -  intracranial extension leptomeninges&#xD;
&#xD;
          -  cerebral parenchyma&#xD;
&#xD;
          -  extension to regional lymph nodes and/or remote metastases.&#xD;
&#xD;
          -  cerebrospinal fluid involvement.&#xD;
&#xD;
          -  Trilateral RB&#xD;
&#xD;
          -  Incapacity to followed the whole treatement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>FOUSSEYNI Mr TRAORE, Dr;</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMCC AND GFAOP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KARIM Mr ASSANI, Dr.</last_name>
    <phone>00243971359726</phone>
    <email>drassanik@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>BRENDA Ms MALLON, MSc</last_name>
    <phone>0033142115411</phone>
    <email>brenda.mallon@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Yalgado Ouedraogo</name>
      <address>
        <city>Ouagadougou</city>
        <zip>03 BP 7022</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BOUDA Dr Chantal, Dr</last_name>
      <email>chantal.bouda@gfaop.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CUK (Cliniques Universitaires de Kinshasa)</name>
      <address>
        <city>Kinshasa</city>
        <zip>BP 12 KIN XI</zip>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aléine BUDIONGO, DR</last_name>
      <phone>+(243)99 81 53 133.</phone>
      <email>albudiongo@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Lubumbashi (CUL)</name>
      <address>
        <city>Lubumbashi</city>
        <zip>BP 1825</zip>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert LUKAMBA, DR</last_name>
      <phone>00(243) 972 262 144</phone>
      <email>robertlukamba@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Treichville à ABIDJAN</name>
      <address>
        <city>Abidjan</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Line Dr COUITCHERE, DOCTOR</last_name>
      <email>line.couitchere@gfaop.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona</name>
      <address>
        <city>Antananarivo</city>
        <state>Ampefiloha</state>
        <zip>BP 4150</zip>
        <country>Madagascar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mbola RAKOTOMAHEFA, DR</last_name>
      <phone>(261) 33 05 055 66</phone>
      <email>mahefambola@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Touré (HGT)</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boubacar TOGO, PROFESSEUR</last_name>
      <phone>+223 66 74 29 04</phone>
      <email>boubacar.togo@gfaop.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Aristide Le Dantec,</name>
      <address>
        <city>Dakar</city>
        <zip>BP 3001</zip>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatou-Binetou DIAGNE AKONDE, DR</last_name>
      <phone>00(221)77 637 40 63</phone>
    </contact>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Congo, The Democratic Republic of the</country>
    <country>Côte D'Ivoire</country>
    <country>Madagascar</country>
    <country>Mali</country>
    <country>Senegal</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</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>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/NCT04425434
org study id: GFAOP RB1
nct id: NCT04425434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As the survival of children with retinoblastoma in high income countries is higher than 95%
      including the bilateral forms this study hopes to improve the outcome in low income countries
      in Africa by improving early diagnosis and early implementation of this protocol of
      therapeutic recommendations for treatment.
In this study we will try to improve the outcome for children with stage II disease. It is
      hoped that we will be able to show that with early intervention correct early diagnosis the
      survival of these children is greatly improved. The collection of data in this observational
      study will allow us to show this improvement, by analysis of stage, treatment and outcome.
observational model: Cohort
time perspective: Prospective
measure: Number of cases with retinoblastoma in each participating hospital.
time frame: 10 years
description: Evaluation of the number of cases registered .
measure: Number of cases with stage 2 disease
time frame: 10 years
description: Evaluation of the number of cases registered with stage 2 disease.
measure: Feasibility of these therapeutic recommendations in an African setting
time frame: 10 years
description: Evaluate the application of these therapeutic recommendations
measure: Evaluating the treatment given.
time frame: 10 years
description: Comparison of treatment given and recommended treatment.
measure: follow up
time frame: 10 years
description: analysis of the number of children alive or dead after treatment
intervention type: Other
intervention name: OBSERVATIONAL
description: We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
last name: FOUSSEYNI Mr TRAORE, Dr;
role: Principal Investigator
affiliation: AMCC AND GFAOP
last name: KARIM Mr ASSANI, Dr.
phone: 00243971359726
email: drassanik@gmail.com
last name: BRENDA Ms MALLON, MSc
phone: 0033142115411
email: brenda.mallon@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Burkina Faso
country: Congo, The Democratic Republic of the
country: Côte D'Ivoire
country: Madagascar
country: Mali
country: Senegal
responsible party type: Sponsor
mesh term: Retinoblastoma