Blood Test for Early Cancer Detection in Hereditary Cancer Syndromes
Tests a blood test for early cancer signs in people with hereditary cancer syndromes.
Plain-language title generated from the registry record
Registry title: CfDNA in Hereditary And High-risk Malignancies 2
Key facts
- Where
- Halifax, Montreal, St. John's, Toronto, and Vancouver, CanadaSee the 8 sites
Where in Canada
- IWK Health CentreHalifax, CanadaTaking people
- Jewish General HospitalMontreal, CanadaTaking people
- Newfoundland and Labrador Health Services (previously Eastern Health)St. John's, CanadaTaking people
- Sinai Health SystemToronto, CanadaTaking people
- The Hospital for Sick ChildrenToronto, CanadaTaking people
- University Health NetworkToronto, CanadaTaking people
- Women's College HospitalToronto, CanadaNot yet recruiting
- BC Cancer AgencyVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT06726642
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection
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.
Inclusion: 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: Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer; 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 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).