Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477681
Status:
RECRUITING
Last Update Posted:
2023-06-06
First Post:
2020-07-15
Brief Title:
Securing Access to Innovative Molecules in Oncology and Hematology for Children Adolescents and Young Adults
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SACHA
Brief 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 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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20192848 | OTHER | CSET number | None |