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, Côte d’Ivoire, Democratic Republic of the Congo, 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.

International Sites

Hopital Yalgado Ouedraogo, Ouagadougou 2357048, Burkina Faso

Status

Recruiting

Address

Hopital Yalgado Ouedraogo

Ouagadougou 2357048, , 03 BP 7022

Site Contact

BOUDA Dr Chantal, Dr

[email protected]

00243971359726

CHU de Treichville à ABIDJAN, Abidjan 2293538, Côte d’Ivoire

Status

Recruiting

Address

CHU de Treichville à ABIDJAN

Abidjan 2293538, ,

Site Contact

Line Dr COUITCHERE, DOCTOR

[email protected]

00243971359726

Kinshasa 2314302, Democratic Republic of the Congo

Status

Recruiting

Address

CUK (Cliniques Universitaires de Kinshasa)

Kinshasa 2314302, , BP 12 KIN XI

Site Contact

Aléine BUDIONGO, DR

[email protected]

+(243)99 81 53 133.

Lubumbashi 922704, Democratic Republic of the Congo

Status

Recruiting

Address

Cliniques Universitaires de Lubumbashi (CUL)

Lubumbashi 922704, , BP 1825

Site Contact

Robert LUKAMBA, DR

[email protected]

00(243) 972 262 144

Antananarivo 1070940, Ampefiloha, Madagascar

Status

Recruiting

Address

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona

Antananarivo 1070940, Ampefiloha, BP 4150

Site Contact

Mbola RAKOTOMAHEFA, DR

[email protected]

(261) 33 05 055 66

CHU Gabriel Touré (HGT), Bamako 2460596, Mali

Status

Recruiting

Address

CHU Gabriel Touré (HGT)

Bamako 2460596, ,

Site Contact

Boubacar TOGO, PROFESSEUR

[email protected]

+223 66 74 29 04

Hôpital Aristide Le Dantec,, Dakar 2253354, Senegal

Status

Recruiting

Address

Hôpital Aristide Le Dantec,

Dakar 2253354, , BP 3001

Site Contact

Fatou-Binetou DIAGNE AKONDE, DR

[email protected]

00(221)77 637 40 63

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