NCT04261972

Cell-free DNA in Hereditary And High-Risk Malignancies 1

Early Detection of Cancer in High-risk Patients Through Cell-free DNA 1

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,416 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (HCS). 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 also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care, and the perceptions of the medical value of test results.

Detailed description

The objective of this protocol is to develop a method to detect early signs of cancer in 'previvors' (people with HCS that do not yet have a cancer diagnosis). This will enable prediction of cancer onset so that patients and their doctors can make decisions to treat or prevent the cancers. HCS patients will be recruited from across Canada to provide blood samples before and after cancer diagnosis. In parallel, there will be development of a circulating tumour DNA (ctDNA) -based test to detect early stage cancer and evaluation on the cost-effectiveness and feasibility of integrating such screening protocols into routine clinical care. In concert, consultation with patients and health care providers will occur to create recommendations for use within clinical care. CHARM1 leads into its follow-up study, CHARM2.

Conditions

• Hereditary Cancer Syndrome

Interventions

Type	Name	Description
GENETIC	Next generation sequencing (NGS)	NGS

Timeline

• Start date: 2018-07-01
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2020-02-10
• Last updated: 2026-01-14

Locations

7 sites across 1 country: Canada