RecruitingNCT06726642

CfDNA in Hereditary And High-risk Malignancies 2

CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection

Sponsor

University Health Network, Toronto

Enrollment

1,000 participants

Start Date

Apr 19, 2024

Study Type

OBSERVATIONAL

Conditions

Hereditary Cancer Syndrome

Summary

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.

Eligibility

Max Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study uses circulating tumor DNA (cfDNA) — tiny fragments of cancer DNA found in the blood — as a liquid biopsy to monitor cancer risk and detect early cancer or recurrence in people with known hereditary cancer syndromes. **You may be eligible if...** - Have a confirmed hereditary cancer syndrome, such as: hereditary breast and ovarian cancer (BRCA mutations), Lynch syndrome (colon cancer risk), Neurofibromatosis type 1, Li-Fraumeni syndrome, PALB2 mutations, or Hereditary Diffuse Gastric Cancer - Willing to provide blood samples for liquid biopsy testing **You may NOT be eligible if...** - Do not have a confirmed pathogenic genetic variant in a qualifying hereditary cancer gene - Are unable to provide consent or blood samples - Have another condition that would make cfDNA results uninterpretable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCell-free DNA analysis

Analysis of cell-free DNA in blood plasma will involve targeted sequencing of key cancer-related genes, cell-free methylated DNA immunoprecipitation and high-throughput sequencing (cfMeDIP-seq), and shallow whole genome sequencing (sWGS).