NCT04423484

Brief Summary

The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 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 Progress56%
Jul 2020Dec 2030

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8.5 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 30, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

8.5 years

First QC Date

June 4, 2020

Last Update Submit

February 27, 2026

Conditions

Nephroblastoma

Outcome Measures

Primary Outcomes (4)

  • Evaluation of the number of cases with local disease.

    By evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.

    5 years

  • Evaluation of the number of cases with stage IV disease.

    By evaluating the initial clinical reports and later histological reports to confirm the stage.

    5 Years

  • Evaluating the treatment given.

    Comparison of treatment given and recommended treatment.

    5 Years

  • Evaluating the follow up after treatment.

    How many children alive or dead after treatment

    5 Years

Secondary Outcomes (1)

  • Why has treatment failed

    5 years

Study Arms (1)

Children with Nephroblastoma

All children coming into the participating units with suspected Nephroblastoma.

Other: Data collection

Interventions

Data collectionOTHER

Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.

Children with Nephroblastoma

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children with local Nephroblastoma in all participating units

You may qualify if:

  • Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.

You may not qualify if:

  • Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle

Ouagadougou, Burkina Faso

RECRUITING

CHU de Treichville à ABIDJAN

Abidjan, Abidjan Autonomous District, Côte d’Ivoire

RECRUITING

CUK (Cliniques Universitaires de Kinshasa)

Kinshasa, 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, Madagascar

RECRUITING

CHU Gabriel Touré (HGT)

Bamako, Mali

RECRUITING

Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001

Dakar, Dakar, Senegal

RECRUITING

MeSH Terms

Conditions

Wilms Tumor

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fatou Binetou Ms DIAGNE AKONDE, Dr

    French Africa Pediatric Oncology Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BRENDA Ms MALLON, MSC

CONTACT

0033142115411brenda.mallon@gustaveroussy.fr

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 9, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

MA(1)BU(1)SE(1)DE(2)CÔ(1)