Actively Recruiting
Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
Led by Mainz Biomed · Updated on 2025-08-12
2700
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is any sex and 45 years of age or older for screening group
- Subject is advised to have or scheduled for a screening colonoscopy
- Subject is at average risk for colorectal cancer with no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
- No family history of colorectal cancer in first degree relatives
- No personal or family history of genetic disorders that increase colorectal cancer risk, including inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome, or other hereditary cancer syndromes
- Subject can understand study procedures and provide informed consent including HIPAA medical release
- Subject is able and willing to provide stool samples within 90 days before colonoscopy and undergo colonoscopy
- For diagnostic group, subject is 18 years of any sex
- Subject is suspected or known to have colorectal cancer or advanced adenoma and not yet treated
- Subject has a diagnostic colonoscopy or surgery scheduled within 90 days of sample collection
- Subject can understand and consent to study procedures and HIPAA medical release
- Subject is able and willing to provide stool samples within 90 days of enrollment before treatment
You will not qualify if you...
- Subject had any precancerous findings on the most recent colonoscopy except non-neoplastic or hyperplastic polyps
- History of abnormal imaging suggesting colorectal cancer
- History of cancers other than colorectal cancer including oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal cancers
- Positive non-invasive screening test within recommended intervals such as fecal occult blood test within 12 months or sDNA-FIT within 36 months
- Colonoscopy in the past 9 years (excluding failed or aborted colonoscopy)
- Prior colorectal resection except for sigmoid diverticular disease
- Colonoscopy indication due to overt rectal bleeding in past 30 days
- Any condition that investigator believes should exclude participation
- For diagnostic group, history of tumor or malignancy other than colorectal cancer in past 5 years
- Prior diagnosis of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Any condition that investigator believes should exclude participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Virtual Research Group
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
L
Lena Krammes, PhD
CONTACT
C
Christian Von Toerne, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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