Cell-free DNA in Hereditary And High-Risk Malignancies

  • STATUS
    Recruiting
  • participants needed
    1500
  • sponsor
    University Health Network, Toronto
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Updated on 19 February 2024
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cancer
blood test
cell-free dna
hereditary cancer
hereditary cancer syndromes

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.

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.

Details
Condition Cancer, Hereditary Neoplastic Syndrome
Age 18years - 100years
Treatment Next generation sequencing (NGS)
Clinical Study IdentifierNCT04261972
SponsorUniversity Health Network, Toronto
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Individual with any known or suspected hereditary cancer predisposition (i.e. individuals with an identified pathogenic or likely pathogenic variant in a cancer predisposition gene and/or a family history of cancer without an identified gene mutation) at any stage in their cancer journey (ie: cancer survivor, unaffected with cancer, current cancer patient)
Individual must be greater than 18 years of age
Individual must speak English or French to participate in the qualitative interview and/or survey

Exclusion Criteria

Individuals that do not meet the outlined inclusion criteria
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