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CfDNA in Hereditary And High-risk Malignancies 2

Recruitingn/aAges any - 90 YearsAllUniversity Health Network, Toronto
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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).
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What it tests

  • Cell-free DNA analysis
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Where

8 sites
BC Cancer Agency
Vancouver, Canada
Newfoundland and Labrador Health Services (previously Eastern Health)
St. John's, Canada
IWK Health Centre
Halifax, Canada
The Hospital for Sick Children
Toronto, Canada
Sinai Health System
Toronto, Canada
University Health Network
Toronto, Canada
Women's College Hospital
Toronto, Canada
Jewish General Hospital
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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