RetinoblastomaGFARB12019NCT04425434
Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
An observational study of Retinoblastoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- OBSERVATIONAL
- How many people
- 3,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Nov 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: all children presenting at participating units who can be treated
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Democratic Republic of the Congo2 sites, 2 recruiting
- Recruiting
CUK (Cliniques Universitaires de Kinshasa)
Kinshasa, Kinshasa City, BP 12 KIN XI
Aléine BUDIONGO, DR, +(243)99 81 53 133., albudiongo@gmail.com
- Recruiting
Cliniques Universitaires de Lubumbashi (CUL)
Lubumbashi, BP 1825
Robert LUKAMBA, DR, 00(243) 972 262 144, robertlukamba@yahoo.fr
Burkina Faso1 site, 1 recruiting
- Recruiting
Hopital Yalgado Ouedraogo
Ouagadougou, 03 BP 7022
BOUDA Dr Chantal, Dr, chantal.bouda@gfaop.org
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CHU de Treichville à ABIDJAN
Abidjan
Line Dr COUITCHERE, DOCTOR, line.couitchere@gfaop.org
Madagascar1 site, 1 recruiting
- Recruiting
HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
Antananarivo, Ampefiloha, BP 4150
Mbola RAKOTOMAHEFA, DR, (261) 33 05 055 66, mahefambola@yahoo.fr
Mali1 site, 1 recruiting
- Recruiting
CHU Gabriel Touré (HGT)
Bamako
Boubacar TOGO, PROFESSEUR, +223 66 74 29 04, boubacar.togo@gfaop.org
Senegal1 site, 1 recruiting
- Recruiting
Hôpital Aristide Le Dantec,
Dakar, BP 3001
Fatou-Binetou DIAGNE AKONDE, DR, 00(221)77 637 40 63
About this study
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.
Read the 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.
- Conditions
- Retinoblastoma
- Being tested
- OBSERVATIONAL
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBSERVATIONALOther
We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with retinoblastoma in each participating hospital.
Evaluation of the number of cases registered .
Measured: 10 years
Number of cases with stage 2 disease
Evaluation of the number of cases registered with stage 2 disease.
Measured: 10 years
Feasibility of these therapeutic recommendations in an African setting
Evaluate the application of these therapeutic recommendations
Measured: 10 years
Evaluating the treatment given.
Comparison of treatment given and recommended treatment.
Measured: 10 years
follow up
analysis of the number of children alive or dead after treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Africa Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FOUSSEYNI Mr TRAORE, Dr;, Principal investigator, AMCC AND GFAOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425434
- Sponsor's protocol ID
- GFAOP RB1
- Acronym
- GFARB12019
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2020
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
- ClinicalTrials.gov ID
- NCT04425434
- Acronym / sponsor ID
- GFARB12019 / GFAOP RB1
- Conditions
- Retinoblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- French Africa Pediatric Oncology GroupUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all children presenting at participating units who can be treated
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBSERVATIONALWe will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed. | Other | – |
Primary outcome
Number of cases with retinoblastoma in each participating hospital.
Time frame: 10 years
Evaluation of the number of cases registered .
Number of cases with stage 2 disease
Time frame: 10 years
Evaluation of the number of cases registered with stage 2 disease.
Feasibility of these therapeutic recommendations in an African setting
Time frame: 10 years
Evaluate the application of these therapeutic recommendations
Evaluating the treatment given.
Time frame: 10 years
Comparison of treatment given and recommended treatment.
follow up
Time frame: 10 years
analysis of the number of children alive or dead after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FOUSSEYNI Mr TRAORE, Dr; principal investigator
AMCC AND GFAOP
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Democratic Republic of the Congo, Burkina Faso, Côte d’Ivoire, Madagascar, Mali and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KARIM Mr ASSANI, Dr. (00243971359726, drassanik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases with retinoblastoma in each participating hospital. (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.