CfDNA in Hereditary And High-risk Malignancies 2

Last updated: December 9, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cell-free DNA analysis

Clinical Study ID

NCT06726642
23-5766
  • Ages < 90
  • All Genders

Study 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

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 anidentified pathogenic variant in the respective cancer predisposition gene, orpatients with uninformative genetic testing but with a family history suggestive ofthe cancer predisposition syndrome).

  • Patients must be receiving standard-of-care clinical assessment for cancer by amanaging physician under a provincial screening program or cancer surveillanceprotocol.

  • All patients must have signed and dated an informed consent form for this study.

Exclusion

Exclusion Criteria:

  • Patients must not have a personal history of cancer diagnosed and treated within 3years prior to the expected first sample collection date for this study. If apatient has a personal history of cancer, treatment must have been completedsuccessfully at least 3 years prior to first study sample collection.

  • Patients diagnosed more than 3 years prior to the expected first sample collectiondate, 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 samplecollection if randomized into the experimental cohort).

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Cell-free DNA analysis
Phase:
Study Start date:
April 19, 2024
Estimated Completion Date:
December 31, 2031

Study Description

Through the CHARM Consortium (www.charmconsortium.ca), we have shown that cell-free DNA (cfDNA) profiling can enable more frequent cancer surveillance from readily accessible blood collections. We are now conducting a prospective, multi-center, randomized control trial of cfDNA testing of 1,000 HCS carriers from across Canada to 1) compare cancer detection rates with and without cfDNA testing, 2) assess cancer stage shift and clinical impact reducing mortality and morbidity cancers, and 3) assess impact of access to cfDNA results on patients' quality of life and psychological distress.

Connect with a study center

  • BC Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Eastern Health

    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • Sinai Health System

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1E8
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Women's College Hospital

    Toronto, Ontario M5S 1B2
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

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