ClinicalTrials.gg
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

From the registry’s dates

  • Started Nov 2020; still recruiting 6 years later.
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

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03

In context

Retinoblastoma

124 studies on the registry are indexed under Retinoblastoma; 23 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 224 across 34 observational studies indexed under Retinoblastoma.

Browse Retinoblastoma studies →

Lead sponsor

French Africa Pediatric Oncology Group is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • cerebrospinal fluid involvement.
  • Trilateral RB
  • Incapacity to followed the whole treatement.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

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.

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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

07

Study locations

7 of 7 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2020 (actual). Primary completion is estimated for Dec 2028, 97 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2020
First posted
Jun 11, 2020
StartActual
Nov 1, 2020
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2030
Last update
Mar 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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