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| ID | Type | Description | Link |
|---|---|---|---|
| 2019/2848 | Other Identifier | CSET number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in therapeutic failure or relapse | Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of a compassionate use or outside marketing authorization, in one of the centers of the SFCE (Société Française des Cancers de l' Enfant) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment maximum 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of compassionate use or outside marketing authorization, in one of the centers of the SFCE (Société Française des Cancers de l' Enfant).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pablo BERLANGA, MD | Contact | +33 (0)1 42 11 42 11 | pablo.berlanga@gustaveroussy.fr | |
| Lee Aymar NDOUNGA DIAKOU, PhD | Contact | +33 (0)1 42 11 42 11 | Leeaymar.NDOUNGA-DIAKOU@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Recruiting | Villejuif | Val de Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37399010 | Background | Berlanga P, Ndounga-Diakou LA, Aerts I, Corradini N, Ducassou S, Strullu M, de Carli E, Andre N, Entz-Werle N, Raimbault S, Roumy M, Renouard M, Gueguen G, Plantaz D, Reguerre Y, Cleirec M, Petit A, Puiseux C, Andry L, Klein S, Bodet D, Kanold J, Briandet C, Halfon-Domenech C, Nelken B, Piguet C, Saumet L, Chastagner P, Benadiba J, Millot F, Pluchart C, Schneider P, Thouvenin S, Gambart M, Serre J, Abbou S, Leruste A, Cayzac H, Gandemer V, Laghouati S, Vassal G. Measuring Safety and Outcomes for the Use of Compassionate and Off-Label Therapies for Children, Adolescents, and Young Adults With Cancer in the SACHA-France Study. JAMA Netw Open. 2023 Jul 3;6(7):e2321568. doi: 10.1001/jamanetworkopen.2023.21568. | |
| 41044876 |
| Label | URL |
|---|---|
| Institutional website (Gustave Roussy) | View source |
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| CHU Amiens | Recruiting | Amiens | France |
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| CHU Angers | Recruiting | Angers | France |
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| CHU Besançon | Recruiting | Besançon | France |
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| CHU Bordeaux | Recruiting | Bordeaux | France |
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| CHU Morvan | Recruiting | Brest | 29200 | France |
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| CHU CAEN | Recruiting | Caen | France |
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| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| Centre Oscar Lambret | Recruiting | Lille | France |
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| CHU Lille | Recruiting | Lille | France |
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| CHU Limoges | Recruiting | Limoges | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| CHU Lyon | Recruiting | Lyon | France |
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| Hôpital de La Timone | Recruiting | Marseille | France |
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| CHU Montpellier | Recruiting | Montpellier | France |
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| CHU Nancy | Recruiting | Nancy | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| CHU Nice | Recruiting | Nice | France |
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| Hôpital Armand Trousseau | Recruiting | Paris | France |
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| Hôpital Robert-Debré | Recruiting | Paris | France |
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| Institut Curie | Recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| CHU Reims | Recruiting | Reims | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU Rouen | Recruiting | Rouen | France |
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| CHU La Réunion | Recruiting | Saint-Denis | France |
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| CHU Saint-Etienne | Recruiting | Saint-Etienne | France |
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| CHU Strasbourg | Recruiting | Strasbourg | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHU Tours | Recruiting | Tours | France |
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| Derived |
| Pasqualini C, Proust S, Schleiermacher G, Gambart M, Jannier S, Petit A, Dupraz C, Thebaud E, Reguerre Y, Ndounga-Diakou LA, Laghouat S, Defachelles AS, Berlanga P. Chemo-Immunotherapy Rescue for High-Risk Neuroblastoma Patients With Progressive Disease Before High-Dose Chemotherapy: Real-World Data From the SACHA-France Study. Pediatr Blood Cancer. 2025 Dec;72(12):e32080. doi: 10.1002/pbc.32080. Epub 2025 Oct 3. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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