StagingGFAOPLH2019NCT05407480
Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma
An observational study of Staging and Therapeutic Recommendations, run by French Africa Pediatric Oncology Group at 1 site in France.
Trial summary
The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data. Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Staging, Therapeutic Recommendations
- What is being tested?
- Observational
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 31 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 0 months to 18 years
- All sexes
- Child, Adult
Study population: All children arriving in one of the participating units : under 18 years of age at diagnosis and suffering from "classical" Hodgkin's disease according to the WHO classification.
Who may be able to join
- under 18 years of age at diagnosis
- suffering from "classical" Hodgkin's disease according to the WHO classification.
- with no history of hematological malignancies or constitutional or acquired immune deficiencies
Who cannot join
- Over 18 years of age at diagnosis
- A history of hematological malignancies or a history of constitutional or a history of acquired immune deficiencies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
FATEN Ben Ayed, Professeur contact
France1 site, 1 recruiting
- Recruiting
Brenda Mallon
Paris, France, 94805
FATEN FEDHILA DR BEN AYED, PROF, Dr. FEDHILA BEN AYED Faten Tunis <faten.fedhila@yahoo.fr>
Aïssata BARRY, DR, 0033 6 61 51 94 74, docteumama@gmail.com
About this study
Official title: Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma
The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.
Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.
Read the detailed description
In high-income countries, therapeutic outcomes exceed 90% and therapeutic de-escalation is necessary to reduce mainly the effects of long-term radiotherapy. Within the same country, there are also differences between the therapeutic protocols used in the different centres.
The Experience of Sub-Saharan African Units of the Franco-African Paediatric Oncology Group (GFAOP) in the treatment of pediatric Hodgkin lymphoma in 104 patients was based on chemotherapy alone. The latter was based on COPP/ABV cures without complementary irradiation adapted to the initial stratification and modulated according to the morphological response. Overall survival at 5 years was 82% at 30 months after a median decrease of 17 months.
It seemed appropriate to bring together in a single committee the representatives of the various pilot units in order to standardize the therapeutic protocols in the African countries.
So with this recommendation the GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.
- Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unit.
- Conditions
- Staging, Therapeutic Recommendations
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Descriptive data will be collected to evaluation compliance with the protocol and to evaluate outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient status
Dead or Alive
Measured: 24 months
Drugs
The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Nov 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StagingStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Africa Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- FATEN Ben Ayed, Professeur, Principal investigator, French Africa Pediatric Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407480
- Sponsor's protocol ID
- GFAOP LH 2019
- Acronym
- GFAOPLH2019
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Children Registered in the RFAOP Register and With a Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05407480
- Acronym / sponsor ID
- GFAOPLH2019 / GFAOP LH 2019
- Conditions
- Staging, Therapeutic Recommendations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- French Africa Pediatric Oncology GroupUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jun 2022 (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 GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.
Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.
Detailed description
In high-income countries, therapeutic outcomes exceed 90% and therapeutic de-escalation is necessary to reduce mainly the effects of long-term radiotherapy. Within the same country, there are also differences between the therapeutic protocols used in the different centres.
The Experience of Sub-Saharan African Units of the Franco-African Paediatric Oncology Group (GFAOP) in the treatment of pediatric Hodgkin lymphoma in 104 patients was based on chemotherapy alone. The latter was based on COPP/ABV cures without complementary irradiation adapted to the initial stratification and modulated according to the morphological response. Overall survival at 5 years was 82% at 30 months after a median decrease of 17 months.
It seemed appropriate to bring together in a single committee the representatives of the various pilot units in order to standardize the therapeutic protocols in the African countries.
So with this recommendation the GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.
- Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children arriving in one of the participating units : under 18 years of age at diagnosis and suffering from "classical" Hodgkin's disease according to the WHO classification.
Key inclusion criteria (3 listed)
- under 18 years of age at diagnosis
- suffering from "classical" Hodgkin's disease according to the WHO classification.
- with no history of hematological malignancies or constitutional or acquired immune deficiencies
Key exclusion criteria (2 listed)
- Over 18 years of age at diagnosis
- A history of hematological malignancies or a history of constitutional or a history of acquired immune deficiencies
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 |
|---|---|---|
| ObservationalDescriptive data will be collected to evaluation compliance with the protocol and to evaluate outcome | Other | – |
Primary outcome
Patient status
Time frame: 24 months
Dead or Alive
Drugs
Time frame: 24 months
The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy
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.
Related trials for Staging
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruiting
68Ga-FAPI PET/CT in the Staging of High-Grade Epithelial Ovarian Cancers: A Pilot Study
High Grade Serous Ovarian Cancer (HGSOC)
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
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.
FATEN Ben Ayed, Professeur contact
FATEN Ben Ayed, Professeur principal investigator
French Africa Pediatric Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staging and Therapeutic Recommendations, run by French Africa Pediatric Oncology Group at 1 site in France.
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 3 inclusion and 2 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 1 site in France. 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 (0033 142115411, brenda.mallon@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient status (time frame: 24 months). The study lists 2 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.