cfDNA Analysis for Cancer Syndromes
(CHARM2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new blood test designed to detect cancer early in individuals with certain hereditary cancer syndromes, such as those linked to specific gene mutations. It compares the effectiveness of this test to regular cancer check-ups. Participants will either receive the new test or continue with their usual care. The study aims to determine if the new test detects cancer earlier and if patients find it beneficial. Eligibility requires having a hereditary cancer syndrome, like Lynch Syndrome or Li-Fraumeni Syndrome, and following a regular cancer screening schedule.
As a Phase 2 trial, this research focuses on evaluating the effectiveness of the new blood test in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in cancer detection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this blood test is safe for detecting early tumors in patients with hereditary cancer syndromes?
Research has shown that circulating cell-free DNA (cfDNA) analysis has been studied for cancer detection. In some studies, cfDNA markers have distinguished cancer patients from healthy individuals, suggesting the test could be a useful tool for cancer screening.
However, challenges exist. For example, certain conditions like obesity can affect the accuracy of cfDNA tests by raising cfDNA levels, potentially leading to incorrect results. Despite these challenges, cfDNA testing has been used safely in other medical areas, as it involves collecting genetic information from a simple blood sample.
While cfDNA analysis appears promising, its use for early cancer detection remains under study. This means not all potential side effects or rare issues are known. Participants should consider these factors when deciding whether to join a trial.12345Why are researchers excited about this trial?
Researchers are excited about cfDNA testing in hereditary and high-risk cancers because it offers a non-invasive way to monitor patients for potential malignancies. Unlike traditional methods, which often rely on imaging or invasive biopsies, cfDNA testing uses simple blood samples to detect cancer-related genetic material. This approach not only reduces the need for more uncomfortable procedures but also allows for more frequent monitoring, potentially catching cancers earlier. Additionally, the feedback loop—where patients receive their results and can undergo further tests if needed—could lead to more personalized and timely care.
What evidence suggests that this blood test is effective for early tumor detection in hereditary cancer syndromes?
Research has shown that cell-free DNA (cfDNA) testing can aid in early cancer detection. High levels of cfDNA have been linked to lung cancer, even in its early stages. One study found that a cfDNA test correctly identified 37% of stage I lung cancer cases and 75% of stage II cases, meaning the test detected cancer in those percentages of patients. Another study demonstrated that cfDNA tests effectively avoided false positives, rarely indicating cancer when none was present. In this trial, participants in the test cohort will undergo cfDNA testing, while those in the control cohort will continue with standard-of-care cancer surveillance. Overall, cfDNA testing shows promise for early cancer detection in individuals at high risk.16789
Who Is on the Research Team?
Raymond Kim, MD
Principal Investigator
Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the experimental cohort provide blood samples tri-annually for cfDNA analysis over 4 years
Follow-up
Participants are monitored for safety and effectiveness after treatment, including follow-up diagnostic procedures for positive cfDNA results
What Are the Treatments Tested in This Trial?
Interventions
- Cell-free DNA analysis
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All participants in the experimental cohort will provide blood samples tri-annually (every 4 months) for 4 years, either at the study hospital or at a local blood laboratory (e.g., LifeLabs). Whenever possible, patients will have research blood collected at the same time as routine blood collections for clinical purposes to avoid additional venipunctures. The samples will undergo cfDNA analysis and all results will be returned to participants by the study team. Participants who receive a "positive" cfDNA assay result will be offered follow-up diagnostic procedures to confirm or rule out the presence of a malignancy. Participants will also complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and understand perceptions of the clinical utility of cfDNA tests for HCS management.
Participants in the control cohort will not receive the cfDNA blood test and will continue to receive standard-of-care cancer surveillance according to current guidelines, as they were prior to study enrollment. Participants will complete questionnaires and semi-structured interviews to explore their experience with cfDNA testing and to understand their perception of the clinical utility of cfDNA tests for HCS management.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Eastern Health
Collaborator
British Columbia Cancer Agency
Collaborator
Jewish General Hospital
Collaborator
Sinai Health System
Collaborator
The Hospital for Sick Children
Collaborator
IWK Health Centre
Collaborator
University of Alberta
Collaborator
Women's College Hospital
Collaborator
Citations
Cell-free DNA analysis in current cancer clinical trials
The results showed that high levels of cfDNA are strongly associated with the presence of lung cancer, regardless of the stage [55,56,57].
Circulating cell-free DNA for cancer early detection - PMC
Another cfDNA methylation early-detection model established in lung cancer showed sensitivities of 37% in stage I and 75.0% in stage II at a ...
Circulating cell-free (cf)DNA analysis: Current technologies ...
Cell-free DNA (cfDNA) analysis has several promising clinical applications in the management of cancer patients, with clinical validity established in ...
Performance of a Cell-Free DNA-Based Multi-cancer ...
This test detected a cancer signal with high specificity and CSO prediction accuracy and moderate sensitivity in symptomatic individuals.
Circulating Tumor DNA detection in cancer - Oxford Academic
It has demonstrated effectiveness in the early detection of treatment resistance.14–17 Patients with high ctDNA levels tend to have poorer survival outcomes ...
Privacy practices using genetic data from cell-free DNA ...
Most laboratories allowed for prolonged use and sharing of cfDNA data, demonstrated incomplete adherence to ASHG privacy recommendations, and provided consents ...
New Perspectives on the Importance of Cell-Free DNA ...
Increased mass of adipose tissue in overweight and obese pregnant women has been shown to result in increased cfDNA levels, often complicating non-invasive ...
8.
guidelines.carelonmedicalbenefitsmanagement.com
guidelines.carelonmedicalbenefitsmanagement.com/cell-free-dna-testing-for-the-management-of-cancer-2023-11-05/ARCHIVED Cell-free DNA Testing (Liquid Biopsy) for the ...
The test includes an algorithmic analysis of findings to report a risk score for colorectal cancer or advanced adenoma.
Challenges in cfDNA Analysis
Uncover challenges in cell-free DNA analysis, from low concentrations to biases. Learn troubleshooting tips and key pitfalls to ensure cfDNA success.
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