NCT05636085

Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma

Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for the Detection of Colorectal Cancer and Advanced Adenoma in an Average Risk Population

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (estimated)
• Sponsor: Mainz Biomed · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.

Detailed description

This study is to validate the clinical performance for the Mainz Biomed Colorectal Cancer Screening Test in an average risk population aged ≥45 years of age. Stool samples will be collected from subjects ≥45 years of age, of average risk for colon cancer, and scheduled to have a screening colonoscopy. The samples will be collected prior to colonoscopy and will be tested with the Mainz Biomed Colorectal Cancer Screening Test. The results will be compared with colonoscopy results to determine test performance.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp
• Colorectal Adenoma

Interventions

Type	Name	Description
DEVICE	Mainz Biomed Colorectal Cancer Screening Test	There is no intervention.

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-06-30
• Completion: 2027-09-01
• First posted: 2022-12-05
• Last updated: 2025-03-05

Regulatory

• FDA-regulated device study