Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMainz Biomed
About this trial
The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
no family history of colorectal cancer (defined as one or more first degree relatives including parent, sibling, or child)
Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
Disqualifiers
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
Subject is any sex and ≥ 18 years of age
Subject is able and willing to give informed consent
Trial population
Two groups will be enrolled. Group 1: Screening group at average risk of colorectal cancer. Group 2: Group that has a suspected or known precancerous lesion or colorectal cancer.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,700 Participants
are grouped into 2 trial groupsGroup A: Individuals aged 45 and over at average risk of colorectal cancer.
Group B: Individuals aged 18 and older suspected or known to have at least one precancerous, intact lesion.
Trial outcomes
Primary outcomes
1
Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
Test results will be used for the feasibility, test optimization, algorithm, and cut- off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov