Observational Study Using cfDNA Assay for Early Detection and Monitoring of Multiple Cancer Types Including Lung Cancer Minimal Residual Disease

What this Trial Is About

Researchers are evaluating a new blood test technology called the genome-wide methylome enrichment platform to detect multiple types of cancer and distinguish between them. This observational case-control study includes people with various cancers such as brain, breast, lung, and others selected for their high prevalence and mortality. The study also aims to assess the platforms ability to detect minimal residual disease and early relapse specifically in lung cancer after treatment. Participants in the study are divided into two groups cases, who are newly diagnosed and have not yet received treatment for cancer, and controls, who have no known cancer. All participants will provide blood samples and clinical data at the start. Those with certain lung cancers will have additional blood draws and follow-ups every 3 to 6 months for up to 3 years after treatment. Controls will have follow-up visits every 6 months for up to 3 years to monitor cancer status. Throughout the study, blood samples from participants with and without cancer will be tested together using a sensitive, noninvasive DNA methylation profiling method that analyzes small amounts of cell-free DNA. Results from this liquid biopsy will not be shared with participants or their doctors. Researchers will track cancer detection over 24 months and monitor clinical outcomes for up to 54 months. Participants health status will be observed during follow-up visits to evaluate the tests performance in detecting cancer early and identifying relapse.

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease