Liquid Biopsy for Brain Tumor

(m-ctDNA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Other invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Varies based on individual treatment plans

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a new method for monitoring high-grade gliomas, aggressive brain tumors, using liquid biopsy. Liquid biopsy detects tumor DNA circulating in the blood, enabling doctors to track tumor changes without surgery. The goal is to create a highly sensitive test for ongoing tumor analysis. Suitable candidates for this trial include those recently diagnosed with high-grade gliomas who are either about to undergo surgery or have had surgery but have not yet started further treatment like radiotherapy.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in glioma monitoring.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on collecting circulating tumor DNA (ctDNA) from patients with high-grade gliomas. Unlike traditional methods, which rely heavily on invasive biopsies to gather tumor information, this approach offers a non-invasive way to monitor the tumor's genetic material through a simple blood test. This could lead to earlier detection of changes in the tumor, allowing for more timely and personalized treatment adjustments. Additionally, it might help in tracking the effectiveness of treatments more efficiently, potentially improving outcomes for patients with these aggressive brain tumors.

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Up to 2 blood samples are collected prior to radiotherapy treatment

1-2 weeks

Up to 2 visits (in-person)

Treatment

Participants undergo radiotherapy treatment; 8 blood samples are collected after treatment

Varies based on individual treatment plans

8 visits (in-person)

Follow-up

Participants are monitored for changes in ctDNA levels following treatment

2 years

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+