Actively Recruiting

Age: 0 - 90Years
All Genders
NCT06726642

CfDNA in Hereditary And High-risk Malignancies 2

Led by University Health Network, Toronto · Updated on 2025-12-16

1000

Participants Needed

8

Research Sites

397 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

B

British Columbia Cancer Agency

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

CfDNA in Hereditary And High-risk Malignancies 2

Who Can Participate

Age: 0 - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a confirmed diagnosis of hereditary breast and ovarian cancer, Lynch Syndrome, Neurofibromatosis type I, Li-Fraumeni Syndrome, PALB2, or Hereditary Diffuse Gastric Cancer, including those with pathogenic variants or suggestive family history
  • Patients receiving standard-of-care clinical cancer assessment under a provincial screening or surveillance program
  • Patients who have signed and dated informed consent for this study
Not Eligible

You will not qualify if you...

  • Patients with cancer diagnosed and treated within 3 years before first study sample collection
  • Patients diagnosed with cancer more than 3 years before first study sample collection who have never been treated
  • Patients currently undergoing investigations for suspected cancer
  • Patients unable to comply with tri-annual blood sample collection if assigned to the experimental group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

BC Cancer Agency

Vancouver, British Columbia, Canada, V5Z 4E6

Not Yet Recruiting

2

Eastern Health

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

Not Yet Recruiting

3

IWK Health Centre

Halifax, Nova Scotia, Canada, B3K 6R8

Not Yet Recruiting

4

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Not Yet Recruiting

5

Sinai Health System

Toronto, Ontario, Canada, M5G 1X5

Actively Recruiting

6

University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

7

Women's College Hospital

Toronto, Ontario, Canada, M5S 1B2

Not Yet Recruiting

8

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Not Yet Recruiting

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Research Team

J

Julia Sobotka, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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