China Colorectal Cancer Screening Trial 1 (C-Cost1): Colonoscopy Versus FIT Versus FIT Plus Blood Test in the Average Risk Population

What this Trial Is About

Colorectal cancer (CRC) is a common and growing health concern in China, with its incidence increasing faster than the global average. Early detection through screening is crucial to reduce the disease burden, especially in average risk populations where most sporadic cases occur. This trial aims to compare different colorectal cancer screening methods to find effective approaches for the average risk population in China. Participants will be randomly assigned to one of three screening groups: a colonoscopy group that receives a single colonoscopy in the first year; a FIT group that undergoes annual fecal immunochemical tests for four years, with positive results followed by diagnostic colonoscopy; and a FIT plus blood test group that combines annual FIT and blood tests detecting cfDNA methylation, also followed by colonoscopy if positive. All groups will have suspicious lesions removed and examined, followed by annual follow-ups and long-term monitoring. During the study, participants will provide fecal, blood, and tissue samples. Researchers will assess colorectal cancer mortality over 10 years as the primary outcome, along with detection rates of advanced lesions, population compliance, cancer stages, incidence rates, quality of life, and cost-effectiveness over 4 to 10 years. This comprehensive approach includes a 4-year screening phase and extended follow-up to monitor outcomes and safety.

China Colorectal Cancer Screening Trial 1 (C-Cost1)