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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Page 1 of 2 (8 locations)

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