Therapeutic Recommendations for Nephroblastoma

Recruiting

• Conditions: Nephroblastoma
• Interventions: Other: Data collection

• Registration Number: NCT04423484
• Lead Sponsor: French Africa Pediatric Oncology Group

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.

Detailed Description

The study is based on results form 2 previous studies carried out by the GFAOP. This study aims to evaluate the capacity of units to follow the recommendations in the protocol. It will look mainly at treatment compliance and outcome for the children treated. The study will also evaluate the improvement in treatment compliance and reporting. This work will help the group to evaluate future needs in participating units and help us adapt treatment programmes to local conditions.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-09
• Study Start: 2020-07-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with Nephroblastoma	Data collection	All children coming into the participating units with suspected Nephroblastoma.

Primary Outcome Measures

Name	Time	Method
Evaluation of the number of cases with stage IV disease.	5 Years	By evaluating the initial clinical reports and later histological reports to confirm the stage.
Evaluating the treatment given.	5 Years	Comparison of treatment given and recommended treatment.
Evaluation of the number of cases with local disease.	5 years	By evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.
Evaluating the follow up after treatment.	5 Years	How many children alive or dead after treatment

Secondary Outcome Measures

Name	Time	Method
Why has treatment failed	5 years	look at precision of reporting by comparing reports (histological and surgical)

Trial Locations

Locations (7)

CHU Gabriel Touré (HGT); 🇲🇱 Bamako, Mali

Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001; 🇸🇳 Dakar, Senegal

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona; 🇲🇬 Antananarivo, Madagascar

Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle; 🇧🇫 Ouagadougou, Burkina Faso

Cliniques Universitaires de Lubumbashi (CUL); 🇨🇩 Lubumbashi, Congo, The Democratic Republic of the

CHU de Treichville à ABIDJAN; 🇨🇮 Abidjan, Côte D'Ivoire

CUK (Cliniques Universitaires de Kinshasa); 🇨🇩 Kinshasa, Congo, The Democratic Republic of the