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Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04425434
Acronym
GFARB12019
Enrollment
3000
Registered
2020-06-11
Start date
2020-11-01
Completion date
2030-12-31
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Brief 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.

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.

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.

Sponsors

French Africa Pediatric Oncology Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of cases with retinoblastoma in each participating hospital.10 yearsEvaluation of the number of cases registered .
Number of cases with stage 2 disease10 yearsEvaluation of the number of cases registered with stage 2 disease.
Feasibility of these therapeutic recommendations in an African setting10 yearsEvaluate the application of these therapeutic recommendations
Evaluating the treatment given.10 yearsComparison of treatment given and recommended treatment.
follow up10 yearsanalysis of the number of children alive or dead after treatment

Countries

Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Madagascar, Mali, Senegal

Contacts

CONTACTKARIM Mr ASSANI, Dr.
drassanik@gmail.com00243971359726
CONTACTBRENDA Ms MALLON, MSc
brenda.mallon@gustaveroussy.fr0033142115411
PRINCIPAL_INVESTIGATORFOUSSEYNI Mr TRAORE, Dr;

AMCC AND GFAOP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026