Circulating Tumor DNA Collection From Patients With High Grade Gliomas

NCT05925218 | Active Not Recruiting

• 1 other identifier: 22-5047
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Radiotherapy as per standard of care RADIATION

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected or pathologically-proven, previously untreated high grade gliomas

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, L4W4C2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection

MeSH Terms

Conditions

Glioma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: September 2, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)