NCT04425434

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
5 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2020Dec 2030

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

8.2 years

First QC Date

June 4, 2020

Last Update Submit

February 27, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Number of cases with retinoblastoma in each participating hospital.

    Evaluation of the number of cases registered .

    10 years

  • Number of cases with stage 2 disease

    Evaluation of the number of cases registered with stage 2 disease.

    10 years

  • Feasibility of these therapeutic recommendations in an African setting

    Evaluate the application of these therapeutic recommendations

    10 years

  • Evaluating the treatment given.

    Comparison of treatment given and recommended treatment.

    10 years

  • follow up

    analysis of the number of children alive or dead after treatment

    10 years

Interventions

We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all children presenting at participating units who can be treated

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Yalgado Ouedraogo

Ouagadougou, 03 BP 7022, Burkina Faso

RECRUITING

CHU de Treichville à ABIDJAN

Abidjan, Côte d’Ivoire

RECRUITING

CUK (Cliniques Universitaires de Kinshasa)

Kinshasa, Kinshasa City, BP 12 KIN XI, Democratic Republic of the Congo

RECRUITING

Cliniques Universitaires de Lubumbashi (CUL)

Lubumbashi, BP 1825, Democratic Republic of the Congo

RECRUITING

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona

Antananarivo, Ampefiloha, BP 4150, Madagascar

RECRUITING

CHU Gabriel Touré (HGT)

Bamako, Mali

RECRUITING

Hôpital Aristide Le Dantec,

Dakar, BP 3001, Senegal

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • FOUSSEYNI Mr TRAORE, Dr;

    AMCC AND GFAOP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KARIM Mr ASSANI, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

November 1, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations