Informations générales (source: ClinicalTrials.gov)
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 (SACHA)
Observational
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
avril 2020
avril 2026
29 juin 2024
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 (OIR) 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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:55 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Pablo BERLANGA | 08/04/2024 13:43:58 | Contacter | ||
| HOPITAL FOCH | Nadia YOUNAN | 21/10/2024 07:07:17 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - Lyon - France | Nadège CORRADINI, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | Sandra RAIMBAULT, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens - Amiens - France | Leslie ANDRY, MD | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Emilie DE CARLI, MD | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon - France | Sébastien KLEIN, MD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Stéphane DUCASSOU, MD | Contact (sur clinicalTrials) | |||
| CHU CAEN - Caen - France | Damien BODET, MD | Contact (sur clinicalTrials) | |||
| CHU Clermont-Ferrand - Clermont-Ferrand - France | Justyna KANOLD | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Claire BRIANDET, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Dominique PLANTAZ, MD | Contact (sur clinicalTrials) | |||
| CHU La Réunion - Saint-Denis - France | Yves REGUERRE, MD | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | Brigitte NELKEN, MD | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Christophe PIGUET, MD | Contact (sur clinicalTrials) | |||
| CHU Lyon - Lyon - France | Carine HALFON-DOMENECH, MD | Contact (sur clinicalTrials) | |||
| CHU Montpellier - Montpellier - France | Laure SAUMET, MD | Contact (sur clinicalTrials) | |||
| CHU Nancy - Nancy - France | Pascal CHASTAGNER, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | Morgane CLEIREC, MD | Contact (sur clinicalTrials) | |||
| CHU Nice - Nice - France | Joy BENADIBA, MD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Frederic MILLOT, MD | Contact (sur clinicalTrials) | |||
| CHU Reims - Reims - France | Claire PUCHART, MD | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Chloé PUISIEUX, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen - Rouen - France | Pascal SCHNEIDER | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - Saint-Étienne - France | Sandrine THOUVENIN, MD | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - Strasbourg - France | Natacha ENTZ-WERLE | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Marion Gambart, MD | Contact (sur clinicalTrials) | |||
| CHU Tours - Tours - France | Jill SERRE, MD | Contact (sur clinicalTrials) | |||
| Hôpital de La Timone - Marseille - France | Nicolas ANDRE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Robert-Debré - Paris - France | Marion STRULLU, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 an ICSID as part of an ATU (nominative
or cohort) 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 ≤ 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 an ICSID as part of an ATU (nominative
or cohort) 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.
- 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