Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OBSERVATIONAL.
- Who it may be relevant to
- Registry conditions: Retinoblastoma. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Madagascar, Mali +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other OBSERVATIONAL
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 outcome measures
- Number of cases with retinoblastoma in each participating hospital. [Time frame: 10 years]
- Number of cases with stage 2 disease [Time frame: 10 years]
- Feasibility of these therapeutic recommendations in an African setting [Time frame: 10 years]
- Evaluating the treatment given. [Time frame: 10 years]
- follow up [Time frame: 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Democratic Republic of the Congo · 2 centers
- CUK (Cliniques Universitaires de Kinshasa) — Kinshasa
- Cliniques Universitaires de Lubumbashi (CUL) — Lubumbashi
Burkina Faso · 1 center
- Hopital Yalgado Ouedraogo — Ouagadougou
Côte d’Ivoire · 1 center
- CHU de Treichville à ABIDJAN — Abidjan
Madagascar · 1 center
- HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona — Antananarivo
Mali · 1 center
- CHU Gabriel Touré (HGT) — Bamako
Senegal · 1 center
- Hôpital Aristide Le Dantec, — Dakar
Identifiers
NCT: NCT04425434 · GFAOP RB1