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

Launched by MAINZ BIOMED · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the Mainz Biomed Colorectal Cancer Screening Test. The goal is to find out how well this test works for detecting colorectal cancer and advanced polyps in people aged 45 and older who are at average risk for these conditions. Participants will be asked to provide stool samples before undergoing a colonoscopy, which is a procedure to check for any signs of cancer or other issues in the colon.

To be eligible for the study, participants must be at least 45 years old and scheduled for a colonoscopy. They should not have a history of colorectal cancer, certain genetic disorders, or any other cancers that could increase their risk. Participants will need to provide consent to take part in the study and will be able to share their health information securely. It's also important to note that this trial is not yet recruiting participants, so there will be no immediate action needed right now.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is any sex and ≥45 years of age
• • 2. Subject must be advised to have or be scheduled for a screening colonoscopy
• 3. Subject is at average risk for colorectal cancer according to the United States Preventive Services Task Force (USPSTF) guidelines, including:
• • no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
• * 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
• • 6. Subject is able and willing to undergo a colonoscopy after providing a stool sample
• Exclusion Criteria:
• • 1. Subject had any precancerous findings on most recent colonoscopy.
• • 2. Subject has a history of abnormal imaging suggesting colorectal cancer (e.g., colonography, MRI, CT, barium enema)
• • 3. Subject has a history of any of the following cancers: oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal
• • 4. Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals
• • 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
• • 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
• • 8. Subject has any condition that in the opinion of the investigator should preclude participation in the study