NCT05636085Not yet recruitingNot Applicable
Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for the Detection of Colorectal Cancer and Advanced Adenoma in an Average Risk Population
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mainz Biomed
- Enrollment
- 15,000
- Primary Endpoint
- Specificity
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Specificity
Time Frame: 18 to 24 months
Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia
Sensitivity Advanced Adenoma
Time Frame: 18 to 24 months
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma
Sensitivity Colorectal Cancer
Time Frame: 18 to 24 months
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer
Secondary Outcomes
- Positive predictive value and negative predictive value(18 to 24 months)
Investigators
Similar Trials
Recruiting
Not Applicable
Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer ScreeningRectum CancerColon CancerNCT02738359Hôpital Edouard Herriot3,250
Completed
Not Applicable
Colorectal cancer screening and early detection in people with Chronic Kidney DiseaseRenal and Urogenital - Kidney diseaseCancer - Bowel - Back passage (rectum) or large bowel (colon)Bowel cancerChronic Kidney DiseaseACTRN12611000538943Dr Germaine Wong1,700
Unknown
Not Applicable
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.Colon AdenomaColorectal CancerNCT05240625National Taiwan University Hospital1,500
Completed
Not Applicable
Population screening for colorectal cancer by colonoscopy or CT-colonography in the Netherlands.Colorectal cancer, adenomatous polyps, screening, colonoscopy, CT-colonographyNL-OMON24258Primary initiators: Academic Medical Center (AMC) and Erasmus Medical Center, Department of Gastroenterology & Hepatology and department of Radiology.7,500
Completed
Not Applicable
Evidence Based Colorectal Cancer Screening for the Uninsured - Sub-studyColorectal CancerNCT02651974University of Texas Southwestern Medical Center8,565