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Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
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
Key Details
Gender
All
Age Range
Any - 25 Years
Study Type
OBSERVATIONAL
Enrollment
1150
Start Date
2020-04-09
Completion Date
2027-04
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Data collection
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.
Locations (32)
Gustave Roussy
Villejuif, Val de Marne, France
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU Morvan
Brest, France
CHU CAEN
Caen, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Centre Oscar Lambret
Lille, France
CHU Lille
Lille, France
CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
CHU Lyon
Lyon, France
Hôpital de La Timone
Marseille, France
CHU Montpellier
Montpellier, France
CHU Nancy
Nancy, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
Hôpital Armand Trousseau
Paris, France
Hôpital Robert-Debré
Paris, France
Institut Curie
Paris, France
CHU Poitiers
Poitiers, France
CHU Reims
Reims, France
CHU Rennes
Rennes, France
CHU Rouen
Rouen, France
CHU La Réunion
Saint-Denis, France
CHU Saint-Etienne
Saint-Etienne, France
CHU Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
CHU Tours
Tours, France