Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Retinoblastoma Clinical Trial

— GFARB12019  

Official title:

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425434
• Other study ID #: GFAOP RB1
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: October 2029

Study information

• Verified date: March 2023
• Source: French Africa Pediatric Oncology Group
• Contact: KARIM Mr ASSANI, Dr.
• Phone: 00243971359726
• Email: drassanik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 2029
• Est. primary completion date: December 2028
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	Hopital Yalgado Ouedraogo	Ouagadougou
Congo, The Democratic Republic of the	CUK (Cliniques Universitaires de Kinshasa)	Kinshasa
Congo, The Democratic Republic of the	Cliniques Universitaires de Lubumbashi (CUL)	Lubumbashi
Côte D'Ivoire	CHU de Treichville à ABIDJAN	Abidjan
Madagascar	HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona	Antananarivo	Ampefiloha
Mali	CHU Gabriel Touré (HGT)	Bamako
Senegal	Hôpital Aristide Le Dantec,	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
French Africa Pediatric Oncology Group

Countries where clinical trial is conducted

Burkina Faso,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  Madagascar,  Mali,  Senegal, 

Outcome

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