Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceRecruiting
CHU Besançon
Coordinator of this site? Confirm its status
BesançonFranceRecruiting
CHU Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
CHU Morvan
Coordinator of this site? Confirm its status
BrestFranceRecruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
CHU Dijon
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Chu Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
CHU Lille
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceRecruiting
CHU Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Chu Lyon
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Hopital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
CHU Nancy
Coordinator of this site? Confirm its status
NancyFranceRecruiting
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
CHU Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Robert Debre
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Armand-Trousseau
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
CHU Reims
Coordinator of this site? Confirm its status
ReimsFranceRecruiting
CHU Rennes
Coordinator of this site? Confirm its status
RennesFranceRecruiting
CHU Rouen
Coordinator of this site? Confirm its status
RouenFranceRecruiting
CHU La Réunion
Coordinator of this site? Confirm its status
Saint-DenisFranceRecruiting
CHU Saint-Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting
CHU Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
CHU Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU Tours
Coordinator of this site? Confirm its status
ToursFranceRecruiting
Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.