m-ctDNA: Circulating Tumor DNA Collection From Patients With High Grade Gliomas

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05925218
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 24.9
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Grade Glioma	Radiation: Radiotherapy as per standard of care

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Circulating Tumor DNA Collection From Patients With High Grade Gliomas
• Actual Study Start Date: Sep 2, 2022
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Outcome Measures

Primary Outcome Measures

1. Feasibility of measuring both the burden and key molecular features of high- grade gliomas (HGG) through profiling of plasma circulating tumour DNA (ctDNA) [2 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	L4W4C2

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT05925218
• Other Study ID Numbers: 22-5047
• First Posted: Jun 29, 2023
• Last Update Posted: Jun 29, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Jun 29, 2023