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.
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
Study Type
OBSERVATIONAL
Enrollment
1,150
In particular, the patient's demographic data, medical history, previous and concomitant treatments, data on the treatment of interest (legal framework, compassionate use/ off-label), dosage, start date, etc.), clinical data will be collected. biological (including molecular profiling of the tumor if available) and radiological follow-up, information on adverse effects. The data to be filled in is that of the CERFA pharmacovigilance form of the ANSM, but additional fields can be created if necessary.
Gustave Roussy
Villejuif, Val de Marne, France
RECRUITINGCHU Amiens
Amiens, France
RECRUITINGCHU Angers
Angers, France
RECRUITINGCHU Besançon
Besançon, France
RECRUITINGCHU Bordeaux
Bordeaux, France
RECRUITINGCHU Morvan
Brest, France
RECRUITINGCHU CAEN
Caen, France
RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Dijon
Dijon, France
RECRUITINGCHU Grenoble
Grenoble, France
RECRUITING...and 22 more locations
Collect access data
Collect access data of children, adolescents and young adults in therapeutic failures and not eligible for a clinical trial with innovative molecules, whether they are targeted therapies, immunotherapies or chemotherapies
Time frame: From enrollment to the end of treatment maximum 7 years
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