GFARB12019: Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Sponsor

French Africa Pediatric Oncology Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT04425434

Collaborator

(none)

3,000

Enrollment

Locations

107

Anticipated Duration (Months)

428.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Other: OBSERVATIONAL

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

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Oct 1, 2029

Outcome Measures

Primary Outcome Measures

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.
Feasibility of these therapeutic recommendations in an African setting [10 years]
Evaluate the application of these therapeutic recommendations
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Yalgado Ouedraogo	Ouagadougou		Burkina Faso	03 BP 7022
2	CUK (Cliniques Universitaires de Kinshasa)	Kinshasa		Congo, The Democratic Republic of the	BP 12 KIN XI
3	Cliniques Universitaires de Lubumbashi (CUL)	Lubumbashi		Congo, The Democratic Republic of the	BP 1825
4	CHU de Treichville à ABIDJAN	Abidjan		Côte D'Ivoire
5	HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona	Antananarivo	Ampefiloha	Madagascar	BP 4150
6	CHU Gabriel Touré (HGT)	Bamako		Mali
7	Hôpital Aristide Le Dantec,	Dakar		Senegal	BP 3001

Sponsors and Collaborators

French Africa Pediatric Oncology Group

Investigators

Principal Investigator: FOUSSEYNI Mr TRAORE, Dr;, AMCC AND GFAOP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

French Africa Pediatric Oncology Group

ClinicalTrials.gov Identifier:

NCT04425434

Other Study ID Numbers:

GFAOP RB1

First Posted:

Jun 11, 2020

Last Update Posted:

Oct 27, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinoblastoma

Study Results

No Results Posted as of Oct 27, 2021