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

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Mainz Biomed
Study ID
NCT06864338
Status
Recruiting
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Conditions

  • Colon Adenocarcinoma
  • Colorectal Cancer Metastatic
  • Colorectal Cancer Screening

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Dec 18, 2022
Status verified
Jun 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
2,700 participants (estimated)

Arms

  • Arm: Individuals aged 45 and over at average risk of colorectal cancer.
    Individuals aged 45 and older that are advised to have or are scheduled for a screening colonoscopy and are at average risk for colorectal cancer.
  • Arm: Individuals aged 18 and older suspected or known to have at least one precancerous, intact lesion.
    Individuals aged 18 and older that are suspected to have at least one advanced precancerous lesion or colorectal cancer. Subjects in this group are those that have been pre-identified with imaging, a positive non-invasive screening test, and/or colonoscopy which requires additional intervention.

Primary Outcome Measure

Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual Research GroupMorrisvilleNorth Carolina27560
Omar Matuk-Villazon, MD
[email protected]
1-833-958-0014
Omar Matuk-Villazon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Morrisville, NC

By research site
Virtual Research Group· Morrisville, NC

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