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Pilot Study for Mainz Biomed Colorectal Cancer Test

This study is looking at how well the Mainz Biomed Colorectal Cancer Test works to find colorectal cancer or advanced adenoma (a type of polyp that can become cancer) in people who are at average risk for colorectal cancer. The main goals are to see if the test is practical to use, to improve the test, and to figure out the best way to interpret its results. You might be able to join if you are 45 years or older, are scheduled for a screening colonoscopy, and have an average risk for colorectal cancer. The study aims to enroll 2700 participants. The current status of the study is unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without providing specific treatments. It plans to include 2700 participants.
What's involved
Each participant will be asked to provide a stool sample. This sample will be sent to a lab for testing, but you will not receive the results.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study will be measured at 3 years.

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NCT06864338

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

Recruiting
Not specifiedAges 18+Observational
Mainz Biomed
~2,700 participants
Updated 2025-08-12 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
Measured over 3 years

Conditions

Colorectal Cancer Screening
Colorectal Cancer Metastatic
Colon Adenocarcinoma

Explore related trials

AdenomaColorectal Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Robert Bresalier, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Lena Krammes, PhD
[email protected]
+49 (0) 613126514-18
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
no family history of colorectal cancer (defined as one or more first degree relatives including parent, sibling, or child)
no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer including:
Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis
Cronkhite Canada Syndrome 4. Subject can understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a Health Insurance Portability and Accountability Act (HIPAA) medical release form 5. Subject is able and willing to provide stool samples within ninety (90) days before the colonoscopy procedure

Exclusion

High-sensitivity fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
sDNA-FIT test within the previous thirty-six (36) months 5. Subject has had a colonoscopy in the previous nine (9) years (not including failed/ aborted colonoscopy e.g., due to failed preparation, inability to reach the cecum, patient instability during the procedure, etc.) 6. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease 7. Indication for colonoscopy due to overt rectal bleeding (e.g., hematochezia or melena) within the previous thirty (30) days (Note: blood on toilet paper, after wiping, does not constitute rectal bleeding) 8. Subject has any condition that in the opinion of the investigator should preclude participation in the study

What this trial measures

  • Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.3 years

    Test results will be used for the feasibility, test optimization, algorithm, and cut- off ranges for the Mainz Biomed Colorectal Cancer Screening Test.