NCT06726642 CfDNA in Hereditary And High-risk Malignancies 2
| NCT ID | NCT06726642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Hereditary Cancer Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-04-19 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Raymond Kim, MD
PRINCIPAL INVESTIGATOR
Princess Margaret Cancer Centre
Frequently Asked Questions
Who can join the NCT06726642 clinical trial?
This trial is open to participants of all sexes, up to 90 Years, studying Hereditary Cancer Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06726642 currently recruiting?
Yes, NCT06726642 is actively recruiting participants. Contact the research team at charm@uhn.ca for enrollment information.
Where is the NCT06726642 trial being conducted?
This trial is being conducted at Vancouver, Canada, St. John's, Canada, Halifax, Canada, Toronto, Canada and 4 additional locations.
Who is sponsoring the NCT06726642 clinical trial?
NCT06726642 is sponsored by University Health Network, Toronto. The principal investigator is Raymond Kim, MD at Princess Margaret Cancer Centre. The trial plans to enroll 1,000 participants.
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