NCT04477681Recruiting
Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults in Therapeutic Failure or Relapse and Not Eligible for a Clinical Trial: a Project of the SFCE
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (Ennov EDC) and relying on the network of Interregional pediatric oncology appeal organizations (RIOs) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1150 (estimated)
- First submitted
- 15 Jul 2020
- Start date
- 9 Apr 2020
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Diseases
- Childhood cancers
- NCT number
- NCT04477681
What you commit to
- Study type: Observational
- Planned participants: 1150
- From 9 Apr 2020 to the primary completion date, 30 Apr 2027
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient included in an early phase clinical trial open to inclusions on French territory.
- Oral refusal to participate by the patient or their legal representatives, in reading the information note specific to the study
- Patient under guardianship or curatorship, deprived of liberty or in the impossibility of expressing opposition to participating in the study
Who the study is looking for
- Age ≤ 25 years old at the time of inclusion in the study
- Patient with a pediatric tumor or leukemia in therapeutic failure or relapse without standard therapeutic options. Exceptionally, patients on the first line of treatment without standard therapeutic options may also be included (eg g: inoperable plexiform neurofibroma and MEK inhibitors, childhood fibrosarcoma and NTRK inhibitors).
- Patient not eligible for an early phase clinical trial open to inclusion on French territory or refusal of inclusion
- Patient treated with a new drug discussed at a RCPPI as part of a compassionate use issued by the ANSM or an off-label prescription of a drug of interest already authorized in adults.
- Patients treated in one of the SFCE centers authorized to prescribe chemotherapy
- Patient who did not object to participate after being informed of the study. The patient must be able and willing to cooperate in the study.
Age in the registry: - to 25 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.