NCT06864338

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

Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test (eAArly DETECT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: Mainz Biomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.

Detailed description

The primary objectives of this study are: 1. Feasibility and test optimization for the Mainz Biomed Colorectal Cancer Screening Test. 2. To develop the test algorithm and establish the clinical cut-off values for the Mainz Biomed Colorectal Cancer Screening Test. Each enrolled participant will be asked to provide a stool sample. The stool sample will be shipped to a laboratory and tested. No results will be provided to the site or the participant.

Conditions

• Colorectal Cancer Screening
• Colorectal Cancer Metastatic
• Colon Adenocarcinoma

Timeline

• Start date: 2022-12-18
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-03-07
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States