<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/NCT03803735</url>
  </required_header>
  <id_info>
    <org_study_id>GFAOP</org_study_id>
    <nct_id>NCT03803735</nct_id>
  </id_info>
  <brief_title>Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa</brief_title>
  <acronym>RFAOP</acronym>
  <official_title>French African Pediatric Oncology Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Africa Pediatric Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>French Africa Pediatric Oncology Group</source>
  <oversight_info>
    <has_dmc>Yes</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 ultimate aim of this registry is to collect precise information concerning the children&#xD;
      coming to oncology units working with the French African Oncology Group. This data will help&#xD;
      to plan and provide correct pediatric oncology treatment and care for this population.&#xD;
&#xD;
      Collecting the data will give much needed information on numbers, stage, treatment and&#xD;
      outcome. The register will give data for local and national health authorities in planning&#xD;
      pediatric cancer programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This register is a registration of all children entering hospital based pediatric oncology&#xD;
      units, working in selected hospitals in French speaking Africa. The data collected includes:&#xD;
      demographic and socioeconomic status as well as clinical status and outcome.&#xD;
&#xD;
      The register also collects information on vital status, treatment abandonment and loss to&#xD;
      follow-up.&#xD;
&#xD;
      Data, collected locally is entered on line using the Research Electronic Data Capture&#xD;
      (REDCap) program. Data are stored under the responsibility of the IT department at Gustave&#xD;
      ROUSSY in Paris- Villejuif.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Number of children with a suspicion of any type of cancer in a given unit</measure>
    <time_frame>in any 12 month period</time_frame>
    <description>Number of children with details of :&#xD;
the type of cancer&#xD;
the stage of the identified cancer coming into a given unit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VITAL STATUS:</measure>
    <time_frame>in any 12 month period</time_frame>
    <description>Dead or alive&#xD;
The number of children living&#xD;
the number of children dead</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Illness status</measure>
    <time_frame>in any 12 month period</time_frame>
    <description>The number of children relapsed,&#xD;
The number of children whos illness has progressed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Status</measure>
    <time_frame>in any 12 month period</time_frame>
    <description>The number of children who had treatment administered,&#xD;
The number of children who abandoned treatment</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Pediatric Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All childre with any pediatric cancer types, coming into any one of the participating units&#xD;
        in a 12 month period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any child presenting at any one of the participating units for treatment&#xD;
&#xD;
          2. Any child with any type of cancer&#xD;
&#xD;
          3. Any child or adolescent less than 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No cancer found&#xD;
&#xD;
          2. Age greater than 18 years -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Brenda Mallon, MSc</last_name>
    <role>Study Director</role>
    <affiliation>French Africa Pediatric Oncology Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brenda MALLON, MSC</last_name>
    <phone>+ 33142115411</phone>
    <email>brenda.mallon@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catherine PATTE, DR</last_name>
    <phone>+ 33142116560</phone>
    <email>catherine.patte@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 CHANTAL, DR</last_name>
    </contact>
  </location>
  <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>Centre Mère et Enfant CME-FCB (Fondation Chantal Biya)</name>
      <address>
        <city>Yaoundé</city>
        <country>Cameroon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angèle PONDY, PROFESSEU</last_name>
      <phone>237) 677 030 892</phone>
      <email>pondyangele@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>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>BUDIONGO Aléine, DR</last_name>
    </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>GFAOP</name>
      <address>
        <city>Villejuif</city>
        <state>Paris</state>
        <zip>00094</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BRENDA MALLON, MSC</last_name>
      <phone>0033661519474</phone>
      <email>brenda.mallon@gustaveroussy.fr</email>
    </contact>
    <contact_backup>
      <last_name>CATHERINE PATTE, DR</last_name>
      <phone>0033142116560</phone>
      <email>catherine.patte@gustaveroussy.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>l'Institut de Cancérologie de Libreville</name>
      <address>
        <city>Libreville</city>
        <country>Gabon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Betty NDAKISSA, DR</last_name>
    </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>Centre National d'Oncologie (CNO)</name>
      <address>
        <city>Nouakchott</city>
        <country>Mauritania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ekhtel Benina ZEIN, DR</last_name>
      <phone>222 45 24 22 32</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CNLC, Centre National de Lutte contre le Cancer</name>
      <address>
        <city>Niamey</city>
        <country>Niger</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aichatou MAHAMADOU, DR</last_name>
    </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>
    <facility>
      <name>CHU Sylvanus Olympio</name>
      <address>
        <city>Lomé</city>
        <zip>BP 57</zip>
        <country>Togo</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koffi Mawuse Jules GUEDENON, DR</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Cameroon</country>
    <country>Congo, The Democratic Republic of the</country>
    <country>Côte D'Ivoire</country>
    <country>France</country>
    <country>Gabon</country>
    <country>Madagascar</country>
    <country>Mali</country>
    <country>Mauritania</country>
    <country>Niger</country>
    <country>Senegal</country>
    <country>Togo</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Units have acess to their own data and can use it for reporting.</ipd_description>
  </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/NCT03803735
org study id: GFAOP
nct id: NCT03803735
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The ultimate aim of this registry is to collect precise information concerning the children
      coming to oncology units working with the French African Oncology Group. This data will help
      to plan and provide correct pediatric oncology treatment and care for this population.

      Collecting the data will give much needed information on numbers, stage, treatment and
      outcome. The register will give data for local and national health authorities in planning
      pediatric cancer programs.
This register is a registration of all children entering hospital based pediatric oncology
      units, working in selected hospitals in French speaking Africa. The data collected includes:
      demographic and socioeconomic status as well as clinical status and outcome.

      The register also collects information on vital status, treatment abandonment and loss to
      follow-up.

      Data, collected locally is entered on line using the Research Electronic Data Capture
      (REDCap) program. Data are stored under the responsibility of the IT department at Gustave
      ROUSSY in Paris- Villejuif.
observational model: Cohort
time perspective: Prospective
measure: Number of children with a suspicion of any type of cancer in a given unit
time frame: in any 12 month period
description: Number of children with details of :
the type of cancer
the stage of the identified cancer coming into a given unit
measure: VITAL STATUS:
time frame: in any 12 month period
description: Dead or alive
The number of children living
the number of children dead
measure: Illness status
time frame: in any 12 month period
description: The number of children relapsed,
The number of children whos illness has progressed.
measure: Treatment Status
time frame: in any 12 month period
description: The number of children who had treatment administered,
The number of children who abandoned treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
last name: Brenda Mallon, MSc
role: Study Director
affiliation: French Africa Pediatric Oncology Group
last name: Brenda MALLON, MSC
phone: + 33142115411
email: brenda.mallon@gustaveroussy.fr
last name: Catherine PATTE, DR
phone: + 33142116560
email: catherine.patte@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
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: Cameroon
country: Congo, The Democratic Republic of the
country: Côte D'Ivoire
country: France
country: Gabon
country: Madagascar
country: Mali
country: Mauritania
country: Niger
country: Senegal
country: Togo
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Units have acess to their own data and can use it for reporting.