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NCT Number: NCT04425434

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

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.

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Key information

Conditions

Retinoblastoma Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases Retinal Neoplasms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Yalgado Ouedraogo, Ouagadougou, Burkina Faso

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

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

Primary outcomes

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

    Time frame: 10 years

    Evaluation of the number of cases registered .

  2. Number of cases with stage 2 disease

    Time frame: 10 years

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

  3. Feasibility of these therapeutic recommendations in an African setting

    Time frame: 10 years

    Evaluate the application of these therapeutic recommendations

  4. Evaluating the treatment given.

    Time frame: 10 years

    Comparison of treatment given and recommended treatment.

  5. follow up

    Time frame: 10 years

    analysis of the number of children alive or dead after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

BRENDA Ms MALLON, MSc

CONTACT

[email protected]

0033142115411

KARIM Mr ASSANI, Dr.

CONTACT

[email protected]

00243971359726

Sponsors and collaborators

Lead sponsor

French Africa Pediatric Oncology Group

Other

Registry information

Acronym: GFARB12019

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Jun 11, 2020
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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