CfDNA in Hereditary And High-risk Malignancies 2

(CHARM2 Trial)

Recruiting at 7 trial locations

Overseen By Julia Sobotka, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Recent cancer, Untreated cancer, Cancer suspicion, Non-compliance

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes. If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. The study will compare cancer detection rates between those receiving the new blood test and those receiving standard care, assess if the test leads to earlier cancer diagnosis, and evaluate its impact on patient outcomes. The study will also use questionnaires and interviews to understand how patients feel about the blood test, its incorporation into routine medical care, and perceptions of the medical value of test results. This research could lead to more effective and less invasive cancer screening for high-risk individuals.

Who Is on the Research Team?

Raymond Kim, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a genetic condition linked to increased cancer risk.

I am under a standard cancer care plan monitored by a doctor.

I have signed the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental cohort provide blood samples tri-annually for cfDNA analysis over 4 years

4 years

Tri-annual visits for blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up diagnostic procedures for positive cfDNA results

4 years

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Test cohort Experimental Treatment 1 Intervention

All participants in the experimental cohort will provide blood samples tri-annually (every 4 months) for 4 years, either at the study hospital or at a local blood laboratory (e.g., LifeLabs). Whenever possible, patients will have research blood collected at the same time as routine blood collections for clinical purposes to avoid additional venipunctures. The samples will undergo cfDNA analysis and all results will be returned to participants by the study team. Participants who receive a "positive" cfDNA assay result will be offered follow-up diagnostic procedures to confirm or rule out the presence of a malignancy. Participants will also complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and understand perceptions of the clinical utility of cfDNA tests for HCS management.

Group II: Control Experimental Treatment 0 Interventions

Participants in the control cohort will not receive the cfDNA blood test and will continue to receive standard-of-care cancer surveillance according to current guidelines, as they were prior to study enrollment. Participants will complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and to understand their perception of the clinical utility of cfDNA tests for HCS management.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Eastern Health

Collaborator

Trials

22

Recruited

29,800+

British Columbia Cancer Agency

Collaborator

Trials

181

Recruited

95,900+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Sinai Health System

Collaborator

Trials

26

Recruited

11,900+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+