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

NCT05636085 | Not Yet Recruiting FDA Device

• 1 other identifier: MNZ-CRC-001
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma

Outcome Measures

Primary Outcomes (3)

• Sensitivity Colorectal Cancer

  Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer

  18 to 24 months

• Sensitivity Advanced Adenoma

  Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma

  18 to 24 months

• Specificity

  Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia

  18 to 24 months

Secondary Outcomes (1)

• Positive predictive value and negative predictive value

  18 to 24 months

Study Arms (1)

Eligible subjects

Subjects ≥45 years of age and at average risk of colorectal cancer.

Device: Mainz Biomed Colorectal Cancer Screening Test

Interventions

Mainz Biomed Colorectal Cancer Screening Test DEVICE

There is no intervention.

Eligible subjects

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects that have been advised to have or are scheduled for a screening colonoscopy.

You may qualify if:

• Subject is any sex and ≥45 years of age
• Subject must be advised to have or be scheduled for a screening colonoscopy
• 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
• 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
• Subject is able and willing to provide stool samples within ninety (90) days before the colonoscopy procedure
• Subject is able and willing to undergo a colonoscopy after providing a stool sample

You may not qualify if:

• Subject had any precancerous findings on most recent colonoscopy.
• Subject has a history of abnormal imaging suggesting colorectal cancer (e.g., colonography, MRI, CT, barium enema)
• Subject has a history of any of the following cancers: oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal
• 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
• Subject has had a colonoscopy in the previous nine (9) years
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
• Indication for colonoscopy due to overt rectal bleeding (e.g., hematochezia or melena) within the previous thirty (30) days
• Subject has any condition that in the opinion of the investigator should preclude participation in the study

Sponsors & Collaborators

• Mainz Biomed: lead

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Danielle Kim Turgeon, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Krammes, PhD

CONTACT

+49 (0) 613126514-18; lena.krammes@mainzbiomed.com

Christian Von Toerne, PhD

CONTACT

+49 (0) 173 1621928; christian.vontoerne@mainzbiomed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share