Therapeutic Recommendations for Nephroblastoma (GFANEPHRO20)

September 11, 2023 updated by: French Africa Pediatric Oncology Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Recruiting
        • Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle
        • Contact:
          • Sonia Ms Kaboret, Dr
        • Contact:
          • kawajo200046@gmail.com
  • Congo, The Democratic Republic of the
      • Kinshasa, Congo, The Democratic Republic of the, BP 12 KIN XI
        • Recruiting
        • CUK (Cliniques Universitaires de Kinshasa)
        • Contact:
      • Lubumbashi, Congo, The Democratic Republic of the, BP 1825
        • Recruiting
        • Cliniques Universitaires de Lubumbashi (CUL)
        • Contact:
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Recruiting
        • CHU de Treichville à ABIDJAN
        • Contact:
          • Line Guei COUITCHERE, MD
  • Madagascar
      • Antananarivo, Madagascar
        • Recruiting
        • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
        • Contact:
        • Principal Investigator:
          • Mbola RAKOTOMAHEFA, Dr
  • Mali
      • Bamako, Mali
        • Recruiting
        • CHU Gabriel Touré (HGT)
        • Contact:
  • Senegal
      • Dakar, Senegal
        • Recruiting
        • Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All children with local Nephroblastoma in all participating units

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with Nephroblastoma
All children coming into the participating units with suspected Nephroblastoma.
Other: Data collection
Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Why has treatment failed
Time Frame: 5 years
look at precision of reporting by comparing reports (histological and surgical)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Africa Pediatric Oncology Group

Investigators

  • Principal Investigator: Fatou Binetou Ms DIAGNE AKONDE, Dr, French Africa Pediatric Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 6, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFANEPHRO2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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