Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

NCT ID: NCT04425434

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2029-10-31

Brief Summary

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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

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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.

Conditions

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Retinoblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Africa Pediatric Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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FOUSSEYNI Mr TRAORE, Dr;

Role: PRINCIPAL_INVESTIGATOR

AMCC AND GFAOP

Locations

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Hopital Yalgado Ouedraogo

Ouagadougou, , Burkina Faso

Site Status RECRUITING

CHU de Treichville à ABIDJAN

Abidjan, , Côte d’Ivoire

Site Status RECRUITING

CUK (Cliniques Universitaires de Kinshasa)

Kinshasa, Kinshasa City, Democratic Republic of the Congo

Site Status RECRUITING

Cliniques Universitaires de Lubumbashi (CUL)

Lubumbashi, , Democratic Republic of the Congo

Site Status RECRUITING

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona

Antananarivo, Ampefiloha, Madagascar

Site Status RECRUITING

CHU Gabriel Touré (HGT)

Bamako, , Mali

Site Status RECRUITING

Hôpital Aristide Le Dantec,

Dakar, , Senegal

Site Status RECRUITING

Countries

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

Central Contacts

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KARIM Mr ASSANI, Dr.

Role: CONTACT

00243971359726

BRENDA Ms MALLON, MSc

Role: CONTACT

0033142115411

Facility Contacts

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BOUDA Dr Chantal, Dr

Role: primary

Line Dr COUITCHERE, DOCTOR

Role: primary

Aléine BUDIONGO, DR

Role: primary

+(243)99 81 53 133.

Robert LUKAMBA, DR

Role: primary

00(243) 972 262 144

Mbola RAKOTOMAHEFA, DR

Role: primary

(261) 33 05 055 66

Boubacar TOGO, PROFESSEUR

Role: primary

+223 66 74 29 04

Fatou-Binetou DIAGNE AKONDE, DR

Role: primary

00(221)77 637 40 63

Other Identifiers

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GFAOP RB1

Identifier Type: -

Identifier Source: org_study_id

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