• Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults

  NCT07727694

  RecruitingObservationalUpdated Jul 27, 2026
• Proof -of -Concept Study To Stratify Targeted Therapies Adapted To Molecular Profiling

  NCT02613962

  CompletedInterventionalNot ApplicableUpdated Apr 1, 2026
• Biological Characterisation of High Risk CHildhood Cancer in Children, Adolescents and Young Adults (MICCHADO)

  NCT03496402

  Active, not recruitingInterventionalNot ApplicableUpdated Mar 18, 2025
• European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

  NCT02813135

  RecruitingInterventionalPhase 1Phase 2Updated Jul 10, 2026
• High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

  NCT04221035

  RecruitingInterventionalPhase 3Updated Jun 26, 2025
• SF1126 for Patients With Relapsed or Refractory Neuroblastoma

  NCT02337309

  TerminatedInterventionalPhase 1Updated Aug 20, 2018

ClinicalTrials.gov ID

NCT04477681

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,150Estimated

Last Update Posted

Mar 31, 2026Actual

Start Date

Apr 9, 2020Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

Official Title

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

Brief Summary

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.

Detailed Description

The objective is to aim for completeness throughout the national territory. This is why this project will be carried out in close collaboration with the RIOs and RCPPI and that of the 31 centers of the SFCE which bring together more than 400 doctors pediatric oncologists and hematologists on the French territory

• Pediatric Cancer

• Data collection

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Andry.Leslie@chu-amiens.fr

EmDeCarli@chu-angers.fr

s1klein@chu-besancon.fr

stephane.ducassou@chu-bordeaux.fr

bodet-d@chu-caen.fr

claire.briandet@chu-dijon.fr

Dplantaz@chu-grenoble.fr

brigitte.nelken@chru-lille.fr

Christophe.Piguet@chu-limoges.fr

carine.halfondomenech@ihope.fr

p.chastagner@chru-nancy.fr

morgane.cleirec@chu-nantes.fr

benadiba.j@chu-nice.fr

isabelle.aerts@curie.fr

f.millot@chu-poitiers.fr

cpluchart@chu-reims.fr

Chloe.PUISEUX@chu-rennes.fr

Pascale.Schneider@chu-rouen.fr

gambart.m@chu-toulouse.fr

J.SERRE@chu-tours.fr