<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/NCT04423484</url>
  </required_header>
  <id_info>
    <org_study_id>GFANEPHRO2020</org_study_id>
    <nct_id>NCT04423484</nct_id>
  </id_info>
  <brief_title>Therapeutic Recommendations for Nephroblastoma</brief_title>
  <acronym>GFANEPHRO20</acronym>
  <official_title>Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.</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>
      The study is based on results form 2 previous studies carried out by the GFAOP. The aim of&#xD;
      this study is to evaluate the capacity of units to follow the recommendations in the&#xD;
      protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is based on results form 2 previous studies carried out by the GFAOP. This study&#xD;
      aims to evaluate the capacity of units to follow the recommendations in the protocol. It will&#xD;
      look mainly at treatment compliance and outcome for the children treated. The study will also&#xD;
      evaluate the improvement in treatment compliance and reporting. This work will help the group&#xD;
      to evaluate future needs in participating units and help us adapt treatment programmes to&#xD;
      local conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Evaluation of the number of cases with local disease.</measure>
    <time_frame>5 years</time_frame>
    <description>By evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the number of cases with stage IV disease.</measure>
    <time_frame>5 Years</time_frame>
    <description>By evaluating the initial clinical reports and later histological reports to confirm the stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the treatment given.</measure>
    <time_frame>5 Years</time_frame>
    <description>Comparison of treatment given and recommended treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the follow up after treatment.</measure>
    <time_frame>5 Years</time_frame>
    <description>How many children alive or dead after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Why has treatment failed</measure>
    <time_frame>5 years</time_frame>
    <description>look at precision of reporting by comparing reports (histological and surgical)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Nephroblastoma</condition>
  <arm_group>
    <arm_group_label>Children with Nephroblastoma</arm_group_label>
    <description>All children coming into the participating units with suspected Nephroblastoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.</description>
    <arm_group_label>Children with Nephroblastoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All children with local Nephroblastoma in all participating units&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will&#xD;
        permit treatment.&#xD;
&#xD;
        .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the&#xD;
        diagnosis Treatment Refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatou Binetou Ms DIAGNE AKONDE, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Africa Pediatric Oncology Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BRENDA Ms MALLON, MSC</last_name>
    <phone>0033142115411</phone>
    <email>brenda.mallon@gustaveroussy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle</name>
      <address>
        <city>Ouagadougou</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Ms Kaboret, Dr</last_name>
    </contact>
    <contact_backup>
      <last_name>kawajo200046@gmail.com</last_name>
    </contact_backup>
  </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) 814024633</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 Guei COUITCHERE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona</name>
      <address>
        <city>Antananarivo</city>
        <country>Madagascar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mbola Mr RAKOTOMAHEFA, Dr</last_name>
      <email>mahefambola@yahoo.fr</email>
    </contact>
    <investigator>
      <last_name>Mbola RAKOTOMAHEFA, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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, Avenue Pasteur, BP 3001</name>
      <address>
        <city>Dakar</city>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DIAGNE AKONDE Fatou-Binetou, Dr</last_name>
      <phone>00(221)77 637 40 63</phone>
      <email>fabakonde@gmail.com</email>
    </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 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>Wilms Tumor</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/NCT04423484
org study id: GFANEPHRO2020
nct id: NCT04423484
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is based on results form 2 previous studies carried out by the GFAOP. The aim of
      this study is to evaluate the capacity of units to follow the recommendations in the
      protocol.
The study is based on results form 2 previous studies carried out by the GFAOP. This study
      aims to evaluate the capacity of units to follow the recommendations in the protocol. It will
      look mainly at treatment compliance and outcome for the children treated. The study will also
      evaluate the improvement in treatment compliance and reporting. This work will help the group
      to evaluate future needs in participating units and help us adapt treatment programmes to
      local conditions.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the number of cases with local disease.
time frame: 5 years
description: By evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.
measure: Evaluation of the number of cases with stage IV disease.
time frame: 5 Years
description: By evaluating the initial clinical reports and later histological reports to confirm the stage.
measure: Evaluating the treatment given.
time frame: 5 Years
description: Comparison of treatment given and recommended treatment.
measure: Evaluating the follow up after treatment.
time frame: 5 Years
description: How many children alive or dead after treatment
measure: Why has treatment failed
time frame: 5 years
description: look at precision of reporting by comparing reports (histological and surgical)
arm group label: Children with Nephroblastoma
description: All children coming into the participating units with suspected Nephroblastoma.
intervention type: Other
intervention name: Data collection
description: Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.
arm group label: Children with Nephroblastoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Fatou Binetou Ms DIAGNE AKONDE, Dr
role: Principal Investigator
affiliation: French Africa Pediatric Oncology Group
last name: BRENDA Ms MALLON, MSC
phone: 0033142115411
email: brenda.mallon@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
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: Wilms Tumor
sharing ipd: Undecided