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

Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for the Detection of Colorectal Cancer and Advanced Adenoma in an Average Risk Population

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Adenoma; Colorectal Polyp
• Intervention / Treatment: Device: Mainz Biomed Colorectal Cancer Screening Test

Detailed Description

This study is to validate the clinical performance for the Mainz Biomed Colorectal Cancer Screening Test in an average risk population aged ≥45 years of age.

Stool samples will be collected from subjects ≥45 years of age, of average risk for colon cancer, and scheduled to have a screening colonoscopy. The samples will be collected prior to colonoscopy and will be tested with the Mainz Biomed Colorectal Cancer Screening Test. The results will be compared with colonoscopy results to determine test performance.

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Lena Krammes, PhD; Phone Number: +49 (0) 613126514-18; Email: lena.krammes@mainzbiomed.com
• Study Contact Backup: Name: Christian Von Toerne, PhD; Phone Number: +49 (0) 173 1621928; Email: christian.vontoerne@mainzbiomed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eligible subjects; Subjects ≥45 years of age and at average risk of colorectal cancer.	Device: Mainz Biomed Colorectal Cancer Screening Test; There is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value and negative predictive value	Determine the positive predictive value and negative predictive value for the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer, Advanced Adenoma, and Advanced Neoplasia	18 to 24 months

Collaborators and Investigators

• Sponsor: Mainz Biomed
• Investigators: Principal Investigator: Danielle Kim Turgeon, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: MNZ-CRC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No