Study to Compare Diagnostic Accuracy of Bacterial Gene Markers Panel M3 and FIT in Detecting Advanced Colorectal Neoplasia

What this Trial Is About

Researchers are evaluating and comparing the accuracy of a stool test called the fecal immunochemical test FIT with a new panel of bacterial gene markers known as M3 for detecting advanced colorectal neoplasia. This study focuses on colorectal cancer, a common cancer with rising cases in younger people, aiming to improve early detection of pre-cancerous growths to reduce mortality. The study involves collecting stool samples from participants who need colonoscopy for screening or symptom investigation. The M3 panel includes four bacterial gene markers Fn, m3, Ch, and Bc shown in earlier studies to have higher sensitivity than FIT for detecting adenomas and colorectal cancer. Participants undergo diagnostic stool tests using FIT and the M3 panel before their colonoscopy. Participants will be evaluated for the sensitivity and specificity of these tests to detect colorectal advanced neoplasia within one month. The study measures include sensitivity for early and invasive colorectal cancer stages, adenomas, sessile serrated lesions, and overall diagnostic accuracy. Microbiota changes after polyp removal will also be assessed. The total study duration is based on the timeframe around colonoscopy and sample analysis.

Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia