Randomized Study of Combined Blood and Stool Tests for Early Detection of Gastrointestinal Cancer with Five-Year Follow-Up in Adults Aged 45 to 74

What this Trial Is About

Researchers are conducting a multicenter, randomized controlled trial to evaluate a new screening approach for gastrointestinal cancers in adults aged 45 to 74. The study aims to see if an active screening method using a combined model of blood and stool tests can reduce deaths from these cancers compared to routine observation. This trial also seeks to validate novel biomarkers and identify factors affecting screening outcomes to help improve prevention strategies. Participants will be randomly assigned to one of two groups. The intervention group will undergo a combined screening test including multi-target blood methylation, fecal FIT, and fecal calprotectin. Those with positive results will have a standard gastrointestinal endoscopy immediately, while those with negative results will continue with routine observation. The control group will only receive routine observation and follow-up. The study follows participants for 5 years to monitor outcomes. During the 5-year follow-up, researchers will collect data on gastrointestinal cancer incidence and mortality through regular contact and medical record review. They will assess differences in cancer-specific death rates between the groups as the main outcome. Additional measures include cancer incidence, test accuracy, all-cause mortality, detection rates of precancerous and early cancers, and endoscopy-related complications. Participants may expect scheduled check-ins and monitoring over this period to support study goals.

A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model