Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02274987
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2014-10-21
Brief Title:
Molecular Profiling for Individualized Treatment Plan for DIPG
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Trial Testing the Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan in Children With Newly Diagnosed DIPG
Status:
COMPLETED
Status Verified Date:
2022-11
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:
None
Brief Summary:
This is a single arm multi-center pilot trial within the Pacific Pediatric Neuro-Oncology Consortium PNOC The current study will use a new treatment approach based on each patients tumor genomic profiling consisting of whole exome sequencing and RNA sequencing as well as predictive modeling
Detailed Description:
The current study will test whether patients gain a clinical benefit from such a treatment approach by comparing overall survival at 12 months OS12 to historical controls Newly diagnosed patients will receive an individualized treatment recommendation including up to four FDA approved drugs based on the molecular profile of the patients tumor as determined by gene expression analysis Whole-exome sequencing WES and predictive modeling age of the patient and other existing medical conditions Initial therapy will consist of standard radiation therapy per institutional guidelines followed by molecular based therapy with FDA approved drugs
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 |
|---|---|---|---|
| 14082 | OTHER | University of California San Francisco | None |