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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03803735
Other study ID # GFAOP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 2030

Study information

Verified date March 2023
Source French Africa Pediatric Oncology Group
Contact Brenda MALLON, MSC
Phone + 33142115411
Email brenda.mallon@gustaveroussy.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 2030
Est. primary completion date December 2025
Accepts healthy volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: 1. Any child presenting at any one of the participating units for treatment 2. Any child with any type of cancer 3. Any child or adolescent less than 18 years of age. Exclusion Criteria: 1. No cancer found 2. Age greater than 18 years -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Burkina Faso Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle Ouagadougou
Burkina Faso Hopital Yalgado Ouedraogo Ouagadougou
Cameroon Centre Mère et Enfant CME-FCB (Fondation Chantal Biya) Yaoundé
Congo, The Democratic Republic of the Cliniques Universitaires de Kinshasa Kinshasa
Congo, The Democratic Republic of the Cliniques Universitaires de Lubumbashi (CUL) Lubumbashi
Côte D'Ivoire CHU de Treichville à ABIDJAN Abidjan
France GFAOP Villejuif Paris
Gabon l'Institut de Cancérologie de Libreville Libreville
Madagascar HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona Antananarivo Ampefiloha
Mali CHU Gabriel Touré (HGT) Bamako
Mauritania Centre National d'Oncologie (CNO) Nouakchott
Niger CNLC, Centre National de Lutte contre le Cancer Niamey
Senegal Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001 Dakar
Togo CHU Sylvanus Olympio Lomé

Sponsors (2)

Lead Sponsor Collaborator
French Africa Pediatric Oncology Group Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

Burkina Faso,  Cameroon,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  France,  Gabon,  Madagascar,  Mali,  Mauritania,  Niger,  Senegal,  Togo, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of children with a suspicion of any type of cancer in a given unit Number of children with details of :
the type of cancer
the stage of the identified cancer coming into a given unit
in any 12 month period
Primary VITAL STATUS: Dead or alive
The number of children living
the number of children dead
in any 12 month period
Primary Illness status The number of children relapsed,
The number of children whos illness has progressed.
in any 12 month period
Primary Treatment Status The number of children who had treatment administered,
The number of children who abandoned treatment
in any 12 month period
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