Circulating Tumor DNA Collection From Patients With High Grade Gliomas

Trial Title: Circulating Tumor DNA Collection From Patients With High Grade Gliomas

NCT ID: NCT05925218

Condition: High Grade Glioma

Conditions: Official terms:
Glioma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: Radiotherapy as per standard of care
Description: Adjuvant Radiotherapy +/- systemic therapy as per standard of care

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: University Health Network

Address:
City: Toronto
Zip: L4W4C2
Country: Canada

Status: Recruiting

Contact:
Last name: David Shultz, MD

Phone: 416 946 4501

Phone ext: 6899
Email: david.shultz@rmp.uhn.ca

Start date: September 2, 2022

Completion date: September 30, 2024

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05925218