NephroblastomaGFANEPHRO20NCT04423484
Therapeutic Recommendations for Nephroblastoma
An observational study of Nephroblastoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Nephroblastoma
- What is being tested?
- Data collection
- How many people
- 1,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Jul 2020to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children with local Nephroblastoma in all participating units
Who may be able to join
- Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.
- .
Who cannot join
- Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Democratic Republic of the Congo2 sites, 2 recruiting
- Recruiting
CUK (Cliniques Universitaires de Kinshasa)
Kinshasa, BP 12 KIN XI
Aléine BUDIONGO, DR, +(243)99 81 53 133., albudiongo@gmail.com
- Recruiting
Cliniques Universitaires de Lubumbashi (CUL)
Lubumbashi, BP 1825
Robert LUKAMBA, DR, 00(243) 814024633, robertlukamba@yahoo.fr
Burkina Faso1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle
Ouagadougou
Sonia Ms Kaboret, Dr
kawajo200046@gmail.com
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CHU de Treichville à ABIDJAN
Abidjan, Abidjan Autonomous District
Line Guei COUITCHERE, MD
Madagascar1 site, 1 recruiting
- Recruiting
HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
Antananarivo
Mbola Mr RAKOTOMAHEFA, Dr, mahefambola@yahoo.fr
Mbola RAKOTOMAHEFA, Dr
Mali1 site, 1 recruiting
- Recruiting
CHU Gabriel Touré (HGT)
Bamako
Boubacar TOGO, PROFESSEUR, +223 66 74 29 04, boubacar.togo@gfaop.org
Senegal1 site, 1 recruiting
- Recruiting
Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001
Dakar, Dakar
DIAGNE AKONDE Fatou-Binetou, Dr, 00(221)77 637 40 63, fabakonde@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephroblastoma
- Being tested
- Data collection
- Medical subject headings
- Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.
| Study group | Role | What they receive |
|---|---|---|
| Children with Nephroblastoma | All children coming into the participating units with suspected Nephroblastoma. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 Years
Evaluating the treatment given.
Comparison of treatment given and recommended treatment.
Measured: 5 Years
Evaluating the follow up after treatment.
How many children alive or dead after treatment
Measured: 5 Years
Secondary outcomes (1)
Why has treatment failed
look at precision of reporting by comparing reports (histological and surgical)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Africa Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatou Binetou Ms DIAGNE AKONDE, Dr, Principal investigator, French Africa Pediatric Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423484
- Sponsor's protocol ID
- GFANEPHRO2020
- Acronym
- GFANEPHRO20
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2020
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.
- ClinicalTrials.gov ID
- NCT04423484
- Acronym / sponsor ID
- GFANEPHRO20 / GFANEPHRO2020
- Conditions
- Nephroblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Africa Pediatric Oncology GroupUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Nephroblastoma | – | Other: Data collectionAll children coming into the participating units with suspected Nephroblastoma. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children with local Nephroblastoma in all participating units
Key inclusion criteria (2 listed)
- Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.
- .
Key exclusion criteria (1 listed)
- Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionClinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up. | Other | Children with Nephroblastoma |
Primary outcome
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.
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.
Evaluating the treatment given.
Time frame: 5 Years
Comparison of treatment given and recommended treatment.
Evaluating the follow up after treatment.
Time frame: 5 Years
How many children alive or dead after treatment
1 secondary outcome
Why has treatment failed
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatou Binetou Ms DIAGNE AKONDE, Dr principal investigator
French Africa Pediatric Oncology Group
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephroblastoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Democratic Republic of the Congo, Burkina Faso, Côte d’Ivoire, Madagascar, Mali and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BRENDA Ms MALLON, MSC (0033142115411, brenda.mallon@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the number of cases with local disease. (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.