Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

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Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04425434
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	French Africa Pediatric Oncology Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	FOUSSEYNI Mr TRAORE, Dr;
Principal Investigator Affiliation	AMCC AND GFAOP
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Burkina Faso, Congo, The Democratic Republic of the, Côte D'Ivoire, Madagascar, Mali, Senegal
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Retinoblastoma

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.