CfDNA in Hereditary And High-risk Malignancies 2
Recruiting · NCT06726642 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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 it is running
8 locations listed.
- BC Cancer Agency - Vancouver, British Columbia, Canada
- Eastern Health - St. John's, Newfoundland and Labrador, Canada
- IWK Health Centre - Halifax, Nova Scotia, Canada
- The Hospital for Sick Children - Toronto, Ontario, Canada
- Sinai Health System - Toronto, Ontario, Canada
- University Health Network - Toronto, Ontario, Canada
- Women's College Hospital - Toronto, Ontario, Canada
- Jewish General Hospital - Montreal, Quebec, Canada