Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-06 @ 10:21 PM
Study NCT ID:
NCT05925218
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2023-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Status:
RECRUITING
Status Verified Date:
2025-02
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:
m-ctDNA
Brief Summary:
Improved outcomes for high-grade gliomas (HGG) require advances in our ability to monitor changes to tumour biology using non-surgical approaches. "Liquid biopsy" is a term used to describe a technique whereby tumour DNA, which has been shed off and then circulates through the blood stream, is detected and analyzed. Our goal is to develop a new type of liquid biopsy that is suitable for primary brain tumours that uses a method that is highly sensitive and allows for ongoing analysis of these tumours.
Detailed Description:
The study objective is to determine the feasibility of measuring both the burden and key molecular features of HGG through profiling of plasma circulating tumour DNA (ctDNA). This will be determined by detecting ctDNA in samples from HGG patients, and measuring changes in ctDNA levels over time following HGG treatment. 50 eligible patients will be enrolled in the study at University Health Network, and up to 10 blood samples will be obtained; up to 2 blood samples prior to their radiotherapy treatment, and 8 blood samples after their radiotherapy treatment. If available, tissue samples that are stored at UHN will also be collected for DNA extraction.
Study Oversight
Has Oversight DMC:
False
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?: