Status:
RECRUITING
CfDNA in Hereditary And High-risk Malignancies 2
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
British Columbia Cancer Agency
Eastern Health
Conditions:
Hereditary Cancer Syndrome
Eligibility:
All Genders
Up to 90 years
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,...
Detailed Description
Through the CHARM Consortium (www.charmconsortium.ca), the investigators have shown that cell-free DNA (cfDNA) profiling can enable more frequent cancer surveillance from readily accessible blood coll...
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).
Key Trial Info
Start Date :
April 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06726642
Start Date
April 19 2024
End Date
December 1 2031
Last Update
December 16 2025
Active Locations (8)
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1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
2
Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
3
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8