Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Recruiting

• Conditions: Retinoblastoma

• Registration Number: NCT04425434
• Lead Sponsor: French Africa Pediatric Oncology Group

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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2028-12
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluating the treatment given.	10 years	Comparison of treatment given and recommended treatment.
follow up	10 years	analysis of the number of children alive or dead after treatment
Feasibility of these therapeutic recommendations in an African setting	10 years	Evaluate the application of these therapeutic recommendations
Number of cases with retinoblastoma in each participating hospital.	10 years	Evaluation of the number of cases registered .
Number of cases with stage 2 disease	10 years	Evaluation of the number of cases registered with stage 2 disease.

Trial Locations

Locations (7)

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona; 🇲🇬 Antananarivo, Ampefiloha, Madagascar

CUK (Cliniques Universitaires de Kinshasa); 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

CHU de Treichville à ABIDJAN; 🇨🇮 Abidjan, Côte D'Ivoire

CHU Gabriel Touré (HGT); 🇲🇱 Bamako, Mali

Hôpital Aristide Le Dantec,; 🇸🇳 Dakar, Senegal

Hopital Yalgado Ouedraogo; 🇧🇫 Ouagadougou, Burkina Faso

Cliniques Universitaires de Lubumbashi (CUL); 🇨🇩 Lubumbashi, Congo, The Democratic Republic of the