Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma (GFARB12019)

March 16, 2023 updated by: French Africa Pediatric Oncology Group
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso, 03 BP 7022
  • Congo, The Democratic Republic of the
      • Kinshasa, Congo, The Democratic Republic of the, BP 12 KIN XI
        • Recruiting
        • CUK (Cliniques Universitaires de Kinshasa)
        • Contact:
      • Lubumbashi, Congo, The Democratic Republic of the, BP 1825
        • Recruiting
        • Cliniques Universitaires de Lubumbashi (CUL)
        • Contact:
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
  • Madagascar
    • Ampefiloha
      • Antananarivo, Ampefiloha, Madagascar, BP 4150
        • Recruiting
        • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
        • Contact:
  • Mali
      • Bamako, Mali
        • Recruiting
        • CHU Gabriel Touré (HGT)
        • Contact:
  • Senegal
      • Dakar, Senegal, BP 3001
        • Recruiting
        • Hôpital Aristide Le Dantec,
        • Contact:
          • Fatou-Binetou DIAGNE AKONDE, DR
          • Phone Number: 00(221)77 637 40 63

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all children presenting at participating units who can be treated

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Africa Pediatric Oncology Group

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

December 1, 2028

Study Completion (Anticipated)

October 1, 2029

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFAOP RB1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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