Pilot Study to Evaluate the Mainz Biomed Test for Detecting Colorectal Cancer and Advanced Adenoma in Adults

What this Trial Is About

Researchers are evaluating the Mainz Biomed Colorectal Cancer Screening Test to see how well it detects colorectal cancer or advanced adenoma in people at average risk for colorectal cancer. The study aims to optimize the test, develop its algorithm, and establish clinical cutoff values over a three-year period. Participants include those advised to have screening colonoscopy as well as those suspected to have precancerous or cancerous lesions. Participants will provide a stool sample that is sent to a laboratory for testing with the Mainz Biomed test. The study groups include individuals aged 45 and older at average risk undergoing screening colonoscopy and individuals aged 18 and older suspected or known to have precancerous lesions or colorectal cancer. No test results will be shared with participants or sites during the study. Throughout the study, participants provide stool samples within 90 days before their colonoscopy or intervention. Researchers will track test feasibility, optimization, and algorithm development as primary outcomes over three years. Participants must be able to consent, provide stool samples, and undergo colonoscopy or surgical intervention as required. The study includes healthy volunteers and is observational in design.

Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test