Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Recruiting now
Conditions studied: Pediatric Cancer
In brief
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.
Key facts
- Study ID
- NCT04477681
- Run by
- Gustave Roussy, Cancer Campus, Grand Paris
- People needed
- 1150
- Starts
- 2020-04-09
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-03-31
Who can join
Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Gustave Roussy — Villejuif, Val de Marne, France (enrolling)
- CHU Amiens — Amiens, France (enrolling)
- CHU Angers — Angers, France (enrolling)
- CHU Besançon — Besançon, France (enrolling)
- CHU Bordeaux — Bordeaux, France (enrolling)
- CHU Morvan — Brest, France (enrolling)
- CHU CAEN — Caen, France (enrolling)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- CHU Dijon — Dijon, France (enrolling)
- CHU Grenoble — Grenoble, France (enrolling)
- Centre Oscar Lambret — Lille, France (enrolling)
- CHU Lille — Lille, France (enrolling)
- CHU Limoges — Limoges, France (enrolling)
- Centre Léon Bérard — Lyon, France (enrolling)
- CHU Lyon — Lyon, France (enrolling)
- Hôpital de La Timone — Marseille, France (enrolling)
- CHU Montpellier — Montpellier, France (enrolling)
- CHU Nancy — Nancy, France (enrolling)
- CHU Nantes — Nantes, France (enrolling)
- CHU Nice — Nice, France (enrolling)
- Hôpital Armand Trousseau — Paris, France (enrolling)
- Hôpital Robert-Debré — Paris, France (enrolling)
- Institut Curie — Paris, France (enrolling)
- CHU Poitiers — Poitiers, France (enrolling)
- CHU Reims — Reims, France (enrolling)
Full record on ClinicalTrials.gov
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