Circulating Tumor DNA Collection From Patients With High Grade Gliomas

High Grade Glioma Clinical Trial

— m-ctDNA  

Official title:

Circulating Tumor DNA Collection From Patients With High Grade Gliomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925218
• Other study ID #: 22-5047
• Status: Recruiting
• Start date: September 2, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients can be enrolled either prior to a planned surgery/biopsy for a suspected HGG or after biopsy/surgery of pathologically proven, previously untreated HGG, prior to adjuvant radiotherapy

• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate

• Age =18 yrs

Exclusion Criteria:

• History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for = 2 years.

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Intervention

Radiation:
• Radiotherapy as per standard of care
Adjuvant Radiotherapy +/- systemic therapy as per standard of care

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of measuring both the burden and key molecular features of high- grade gliomas (HGG) through profiling of plasma circulating tumour DNA (ctDNA)	Feasibility in this context will be defined by 1) detecting ctDNA in samples from HGG patients and 2) measuring changes in levels of specific ctDNA fragments following HGG treatment	2 years