Clinical trial · Observational
Cell-free DNA in Hereditary And High-Risk Malignancies 1
Early Detection of Cancer in High-risk Patients Through Cell-free DNA 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next generation sequencing (NGS) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CHARM
- description
- Patients identified with hereditary breast and ovarian cancer syndrome (germline BRCA1 or BRCA2 carrier) or Lynch syndrome (germline variant in EPCAM, MLH1, MSH2, MSH6, or PMS2).
- interventionNames
- Genetic: Next generation sequencing (NGS)
Primary outcomes (6)
- measure
- Collection of biospecimens from 1500 HSC carriers.
- timeFrame
- up to 4 years
- description
- Facilitate and streamline the collection, banking, and annotation of plasma samples and tumour tissue (if applicable) across Canada.
- measure
- Collection of clinical data from 1500 HSC carriers.
- timeFrame
- up to 4 years
- description
- Extract clinical data for all study participants from electronic medical records. Data collection will include family history and medical history.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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). 2. Individual must be greater than 18 years of age 3. Individual must speak English or French to participate in the qualitative interview and/or survey Exclusion Criteria: 1\. Individuals that do not meet the outlined inclusion criteria.
References
Publications (0)
Data not yet available