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RecruitingNCT04425434GFARB12019Updated Mar 2, 2026

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

An observational study in Retinoblastoma, sponsored by French Africa Pediatric Oncology Group. Recruiting at 7 sites in 6 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by French Africa Pediatric Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Retinoblastoma

Browse trials for

03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

all children presenting at participating units who can be treated

Inclusion criteria

  • Unilateral intraocular Retinoblastoma (RB)
  • Unilateral extraocular intraorbital (RB)
  • Bilateral intraocular (RB)
  • bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.

Exclusion criteria

Exclusion Criteria:

  • Externalized tumor mass
  • massive extension to optic nerve up to optical channeltumor
  • intracranial extension leptomeninges
  • cerebral parenchyma
  • extension to regional lymph nodes and/or remote metastases.
  • cerebrospinal fluid involvement.
  • Trilateral RB
  • Incapacity to followed the whole treatement.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • OtherOBSERVATIONAL

    We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.

05

What researchers measure

Primary outcomes

  1. Number of cases with retinoblastoma in each participating hospital.

    Evaluation of the number of cases registered .

    Time frame: 10 years

  2. Number of cases with stage 2 disease

    Evaluation of the number of cases registered with stage 2 disease.

    Time frame: 10 years

  3. Feasibility of these therapeutic recommendations in an African setting

    Evaluate the application of these therapeutic recommendations

    Time frame: 10 years

  4. Evaluating the treatment given.

    Comparison of treatment given and recommended treatment.

    Time frame: 10 years

  5. follow up

    analysis of the number of children alive or dead after treatment

    Time frame: 10 years

06

Study locations

7 of 7 sites recruiting
  • Hopital Yalgado Ouedraogo
    Ouagadougou, 03 BP 7022, Burkina Faso
    Recruiting
  • CHU de Treichville à ABIDJAN
    Abidjan, Côte d’Ivoire
    Recruiting
  • CUK (Cliniques Universitaires de Kinshasa)
    Kinshasa, Kinshasa City BP 12 KIN XI, Democratic Republic of the Congo
    Recruiting
  • Cliniques Universitaires de Lubumbashi (CUL)
    Lubumbashi, BP 1825, Democratic Republic of the Congo
    Recruiting
  • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
    Antananarivo, Ampefiloha BP 4150, Madagascar
    Recruiting
  • CHU Gabriel Touré (HGT)
    Bamako, Mali
    Recruiting
  • Hôpital Aristide Le Dantec,
    Dakar, BP 3001, Senegal
    • Fatou-Binetou DIAGNE AKONDE, DR · Contact · 00(221)77 637 40 63
    Recruiting
07

Registry details

Key details

Study ID
NCT04425434
Lead sponsor
French Africa Pediatric Oncology Group
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Nov 1, 2020
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 2, 2026

Study contacts

KARIM Mr ASSANI, Dr.
Contact
drassanik@gmail.com
00243971359726
BRENDA Ms MALLON, MSc
Contact
brenda.mallon@gustaveroussy.fr
0033142115411
FOUSSEYNI Mr TRAORE, Dr;
principal investigator · AMCC AND GFAOP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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