Validity and diagnostic performance of an optimized multi-target stool nucleic acid test combined with FIT (Mainz Biomed Colorectal Cancer Screening Test) for early detection of colorectal cancer and advanced precancerous lesions in colo
- Conditions
- Z12.1Special screening examination for neoplasm of intestinal tract
- Registration Number
- DRKS00027888
- Lead Sponsor
- Mainz Biomed Germany GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
Women or men aged 40-85 years who gave their written informed consent and who shall undergo colonoscopy for the purpose of
• Screening colonoscopy for CRC through referral by medical institution, by insurance or by self-referral
• Diagnostic or theraputic colonoscopy through referral by medical institution, by insurance or by self-referral
• Treatment naïve patients who have already been diagnosed with CRC after an initial colonoscopy within the past 3 months and are about to receive their first treatment.
• Contraindications to colonoscopy
• Subject has had a positive DNA based stool test within the previous 2 years
• Subject has a history of CRC or advanced premalignant lesion in colon (Exception: diagnosis of CRC or advanced premalignant lesion by colonoscopy/PAD within the past 3 months which is so far untreated)
• Subject has a diagnosis of diverticulosis/diverticulitis coli
• Subject has a diagnosis or medical/family history of any of the following conditions, including:
o Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP and Gardner's syndrome)
o Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome)
o Other hereditary cancer syndromes including but are not limited to Peutz- Jegers Syndrome, MUTYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis
• Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease
• Subject has a diagnosis of Cronkhite-Canada Syndrome
• Subject has any condition that in the opinion of the investigator should preclude participation in the study
• Subject is unwilling to give informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To estimate sensitivity for CRC with the Mainz Biomed Colorectal Cancer Screening Test <br>-To estimate specificity for CRC with the Mainz Biomed Colorectal Cancer Screening Test<br>
- Secondary Outcome Measures
Name Time Method To estimate sensitivity for advanced precancerous lesions in colon with the Mainz Biomed Colorectal Cancer Screening Test <br>-To estimate specificity for advanced precancerous lesions in colon with the Mainz Biomed Colorectal Cancer Screening Test <br>-To estimate specificity for no colorectal findings (normal colon) with the Mainz Biomed Colorectal Cancer Screening Test <br>-To determine stability of frozen samples for up to 15 months<br>