Blood test for early cancer detection in hereditary cancer patients

CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection

This study is testing a new blood test to see if it can help find early tumors in people with hereditary cancer syndromes better than the usual methods.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: N/A to 90 Years
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Locations: 8 sites (Vancouver, British Columbia and 7 other locations)
• Trial ID: NCT06726642 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of a new blood test that detects early tumors in patients with hereditary cancer syndromes. It will compare cancer detection rates between those using the new test and those receiving standard care, while also assessing the impact on cancer stage, patient outcomes, and quality of life. The study involves a multi-center approach across Canada, utilizing questionnaires and interviews to gather patient feedback on the test's integration into routine care. The goal is to enhance cancer screening methods for high-risk individuals through less invasive techniques.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed hereditary cancer syndromes such as BRCA1, BRCA2, Lynch Syndrome, and others.

Not a fit: Patients with a personal history of cancer diagnosed and treated within the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier cancer detection and improved outcomes for patients with hereditary cancer syndromes.

How similar studies have performed: Previous studies have shown promise in using cfDNA profiling for cancer surveillance, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with a confirmed diagnosis of hereditary breast and ovarian cancer (HBOC), Lynch Syndrome (LS), Neurofibromatosis type I (NF1), Li-Fraumeni Syndrome (LFS), PALB2, and Hereditary Diffuse Gastric Cancer (HDGC), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome).
* Patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol.
* All patients must have signed and dated an informed consent form for this study.

Exclusion Criteria:

* Patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. If a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection.
* Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.
* Patients undergoing investigations for a clinical suspicion of cancer.
* Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).

Where this trial is running

Vancouver, British Columbia and 7 other locations

• BC Cancer Agency — Vancouver, British Columbia, Canada (NOT_YET_RECRUITING)
• Eastern Health — St. John's, Newfoundland and Labrador, Canada (NOT_YET_RECRUITING)
• IWK Health Centre — Halifax, Nova Scotia, Canada (NOT_YET_RECRUITING)
• The Hospital for Sick Children — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
• Sinai Health System — Toronto, Ontario, Canada (RECRUITING)
• University Health Network — Toronto, Ontario, Canada (RECRUITING)
• Women's College Hospital — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
• Jewish General Hospital — Montreal, Quebec, Canada (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Raymond Kim, MD — Princess Margaret Cancer Centre
• Study coordinator: Julia Sobotka, MSc

Conditions: Hereditary Cancer Syndrome, cfDNA, cell-free DNA, Hereditary cancer syndrome, BRCA1, BRCA2, Lynch Syndrome, Hereditary breast and ovarian cancer