A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer

What this Trial Is About

Colorectal cancer is a common and deadly disease, ranking third in diagnosis and second in mortality worldwide. Traditional screening methods detect cancer but not the early precursor lesions called adenomas, which limits their ability to prevent cancer. This research aims to develop a highly sensitive, specific, and cost-effective blood test using advanced machine learning and biological analyses to detect both advanced adenomas and colorectal cancer early. The study will develop this innovative blood test in four phases: first, by profiling circulating microRNAs (cf-miRNA and exo-miRNA) to select biomarker candidates; second, using machine learning to create algorithms for detecting advanced adenomas and colorectal cancer separately; third, combining these algorithms into detection signatures; and fourth, validating these signatures with diverse patient groups. This non-invasive test uses a single blood draw and aims to improve patient compliance and resource use compared to invasive screening methods like endoscopy. Participants in this observational study have had colonoscopies and will provide blood samples before any cancer treatment. Researchers will analyze the blood samples for microRNA biomarkers and compare the test results to colonoscopy findings. Primary outcomes include the sensitivity of the test in detecting advanced adenomas and colorectal cancer. Secondary outcomes include specificity and accuracy. The study monitors participants for about one year and includes diverse groups based on colonoscopy results, ranging from no disease to colorectal cancer.

Early Detection of Advanced Adenomas and Colorectal Cancer