Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorMainz Biomed
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is any sex and ≥45 years of age
Subject must be advised to have or be scheduled for a screening colonoscopy
no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
Disqualifiers
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
Trial population
Subjects that have been advised to have or are scheduled for a screening colonoscopy.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Mainz Biomed Colorectal Cancer Screening Test
DeviceThere is no intervention.
Treatment groups
15,000 Participants
are divided into 1 treatment groupGroup A: Eligible subjects1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity Colorectal Cancer
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer
Time frame
18 to 24 months2
Sensitivity Advanced Adenoma
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma
Time frame
18 to 24 months3
Specificity
Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia
Time frame
18 to 24 monthsSecondary outcomes
1
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
Time frame
18 to 24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: