Testing a new stool test for colorectal cancer detection

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

This study is testing a new stool test to see if it can help find colorectal cancer and advanced growths in people aged 45 and older who are at average risk.

Quick facts

• Study type: Observational
• Enrollment: 2700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mainz Biomed (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Morrisville, North Carolina)
• Trial ID: NCT06864338 on ClinicalTrials.gov

What this trial studies

This study evaluates the Mainz Biomed Colorectal Cancer Screening Test for its effectiveness in detecting colorectal cancer and advanced adenomas in individuals at average risk. Participants aged 45 and older will provide stool samples, which will be analyzed in a laboratory to assess the test's feasibility and optimize its algorithm. The study aims to establish clinical cut-off values for the test, although results will not be shared with participants or the site. This observational study focuses on improving colorectal cancer screening methods.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45 and older who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy.

Not a fit: Patients with a history of colorectal cancer, adenomatous polyps, inflammatory bowel disease, or genetic predispositions to colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could enhance early detection of colorectal cancer and advanced adenomas, potentially leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in using stool tests for colorectal cancer screening, indicating that this approach is supported by prior research.

Eligibility criteria

Group 1: Screening Group 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 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
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. This does not include non-neoplastic polyps and/or hyperplastic polyps of any size (Note: tissue biopsies that result in no histopathology findings are acceptable) 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 (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

Group 2: Diagnostic Group Inclusion Criteria

1. Subject is any sex and ≥ 18 years of age
2. Subject is able and willing to give informed consent
3. Through imaging, a positive non-invasive screening test, or colonoscopy requiring additional intervention subject is suspected or known to have Colorectal Cancer or Advanced Adenoma
4. Subject has not yet been treated (e.g., ablation, surgical resection, radiation, chemotherapy, etc.) and still has at least one intact or partially intact lesion
5. Subject must have a diagnostic colonoscopy or surgical intervention scheduled within 90 days of sample collection
6. 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
7. Subject is able and willing to provide stool samples within ninety (90) days of enrollment and before any treatment procedures are initiated Exclusion Criteria

1\. Subject has had a tumor or malignancy other than colorectal cancer identified within the past five years (does not include non-melanoma skin cancer) 2. Subject has been previously diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's disease) 3. Subject has any condition that in the opinion of the investigator should preclude participation in the study

Where this trial is running

Morrisville, North Carolina

• Virtual Research Group — Morrisville, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Robert Bresalier, MD — M.D. Anderson Cancer Center
• Study coordinator: Lena Krammes, PhD

Conditions: Colorectal Cancer Screening, Colorectal Cancer Metastatic, Colon Adenocarcinoma, Stool test, Colorectal cancer screening test, advanced adenoma screeing test