Current and new frontiers in hereditary cancer surveillance: Opportunities for liquid biopsy.
Kirsten M Farncombe, Derek Wong, Maia L Norman...
https://pubmed.ncbi.nlm.nih.gov/37802042Actively Recruiting
Age: 0 - 90Years
All Genders
ID06726642
CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection
Led by University Health Network, Toronto · Updated on 2025-12-16
1000
Participants Needed
8
Research Sites
104 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
Researchers are studying an experimental blood test that detects early tumors in patients with hereditary cancer syndromes. This test, called cell-free DNA (cfDNA) analysis, aims to improve cancer screening by identifying cancer sooner than standard methods. The study compares cancer detection rates and timing between patients receiving cfDNA testing and those receiving regular care, while also exploring the impact on patients' quality of life and psychological well-being. Participants are divided into two groups: the experimental group provides blood samples every four months for four years for cfDNA testing, with results given back to them. Those with positive results will be offered follow-up tests to confirm cancer presence. The control group continues with their usual cancer surveillance without cfDNA testing. Both groups complete questionnaires and interviews to share their experiences and views on the blood test. During the study, participants attend regular blood sample collections, often coordinated with routine clinical blood draws to reduce extra procedures. Researchers measure cancer detection rates over four years and assess if cfDNA testing leads to earlier cancer diagnosis. They also evaluate participants' cancer-related worry, anxiety, and quality of life. The study lasts for four years, with ongoing monitoring and support to understand the test's clinical and personal impact.
CONDITIONS
Brief Title
CfDNA in Hereditary And High-risk Malignancies 2
Who Can Participate
Age: 0 - 90Years
All Genders
Eligibility Criteria
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 gene variants or strong family history
- Receiving standard-of-care cancer screening or surveillance under a managing physician
- Signed and dated informed consent form for the study
You will not qualify if you...
- Personal history of cancer diagnosed and treated within 3 years prior to first sample collection
- Diagnosed with cancer more than 3 years before first sample but never treated
- Currently undergoing investigations for suspected cancer
- 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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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Monitoring
Duration - 4 years
Participants provide blood samples tri-annually for cell-free DNA analysis and complete questionnaires and interviews to assess their experience and perceptions.
Blood sample collections every 4 months (tri-annually) and periodic questionnaires/interviews
Diagnostic Evaluation
Duration - Variable, based on individual follow-up needs
Participants with a positive cfDNA test result are offered follow-up diagnostic procedures to confirm or rule out cancer.
Additional visits as needed for diagnostic procedures following positive test results
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
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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