Therapeutic Recommendations for Nephroblastoma

Nephroblastoma Clinical Trial

— GFANEPHRO20  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423484
• Other study ID #: GFANEPHRO2020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: September 30, 2026

Study information

• Verified date: March 2023
• Source: French Africa Pediatric Oncology Group
• Contact: BRENDA Ms MALLON, MSC
• Phone: 0033142115411
• Email: brenda.mallon[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephroblastoma
• Wilms Tumor

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle	Ouagadougou
Congo, The Democratic Republic of the	CUK (Cliniques Universitaires de Kinshasa)	Kinshasa
Congo, The Democratic Republic of the	Cliniques Universitaires de Lubumbashi (CUL)	Lubumbashi
Côte D'Ivoire	CHU de Treichville à ABIDJAN	Abidjan
Madagascar	HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona	Antananarivo
Mali	CHU Gabriel Touré (HGT)	Bamako
Senegal	Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
French Africa Pediatric Oncology Group

Countries where clinical trial is conducted

Burkina Faso,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  Madagascar,  Mali,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Evaluating the treatment given.	Comparison of treatment given and recommended treatment.	5 Years
Primary	Evaluating the follow up after treatment.	How many children alive or dead after treatment	5 Years
Secondary	Why has treatment failed	look at precision of reporting by comparing reports (histological and surgical)	5 years