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Recruiting NCT04423484

Therapeutic Recommendations for Nephroblastoma

Observational Nephroblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Nephroblastoma. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Madagascar, Mali +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.

Overview

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.

Interventions

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

Primary outcome measures

  • Evaluation of the number of cases with local disease. [Time frame: 5 years]
  • Evaluation of the number of cases with stage IV disease. [Time frame: 5 Years]
  • Evaluating the treatment given. [Time frame: 5 Years]
  • Evaluating the follow up after treatment. [Time frame: 5 Years]
Secondary outcome measures (1)
  • Why has treatment failed [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

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

.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Democratic Republic of the Congo · 2 centers
  • CUK (Cliniques Universitaires de Kinshasa) — Kinshasa
  • Cliniques Universitaires de Lubumbashi (CUL) — Lubumbashi
Burkina Faso · 1 center
  • Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle — Ouagadougou
Côte d’Ivoire · 1 center
  • CHU de Treichville à ABIDJAN — Abidjan
Madagascar · 1 center
  • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona — Antananarivo
Mali · 1 center
  • CHU Gabriel Touré (HGT) — Bamako
Senegal · 1 center
  • Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001 — Dakar

Identifiers

NCT: NCT04423484 · GFANEPHRO2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗