Study to Collect Blood Samples and Clinical Data to Improve Early Detection of Colorectal Cancer Using a Blood Test in U.S. Adults Aged 45 to 84

What this Trial Is About

Researchers are conducting an observational study to evaluate and optimize a blood test that detects colorectal cancer CRC by analyzing circulating free DNA cfDNA markers. This test focuses on detecting advanced precancerous lesions and early CRC in the United States population. The study aims to improve the performance of this blood-based assay for early CRC detection by collecting blood samples and clinical data from different participant groups. Participants include newly diagnosed CRC patients scheduled for surgery but not yet treated, patients confirmed with CRC by colonoscopy but not scheduled for surgery, and individuals at average risk undergoing routine colonoscopy screening. Blood samples and clinical information will be collected prospectively from these groups to support assay development and machine learning model training. During the study, participants will provide blood samples and clinical data before any cancer treatment. Researchers will analyze these samples to develop and validate the blood test. The study includes baseline assessment for assay development and ongoing machine learning training extending up to 24 months after the last participants involvement. Participants may be monitored for clinical data and sample collection over this period to support assay evaluation and optimization.

Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance