Z12.1
Conditions
Interventions
Group 1: Participants who either have a screening colonoscopy, are referred for diagnostic colonoscopy, or have been diagnosed with a colorectal lesion (therapy-naive) that could be part of this study
Sponsors
Mainz Biomed Germany GmbH
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -To estimate sensitivity for CRC with the Mainz Biomed Colorectal Cancer Screening Test -To estimate specificity for CRC with the Mainz Biomed Colorectal Cancer Screening Test | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate sensitivity for advanced precancerous lesions in colon with the Mainz Biomed Colorectal Cancer Screening Test -To estimate specificity for advanced precancerous lesions in colon with the Mainz Biomed Colorectal Cancer Screening Test -To estimate specificity for no colorectal findings (normal colon) with the Mainz Biomed Colorectal Cancer Screening Test -To determine stability of frozen samples for up to 15 months | — |
Countries
Denmark, Germany, Norway
Contacts
Public ContactMatthias Dollinger
Klinikum Landshut
Outcome results
None listed