A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

Korábbi kezelés

• Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
• Has completed Cologuard or Epi proColon testing within the previous 3 years.
• Has undergone a CT colonography in the prior 4 years.
• History of any malignancy within prior 5 years.
• Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
• Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.

Más betegség

• History of colorectal cancer.
• Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
• Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]).
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

Életkor

• Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age <60 years or with more than one first-degree relative diagnosed with CRC at any age.

Egyéb

• Undergoing colonoscopy for investigation of CRC risk symptoms
• Has undergone colonoscopy within preceding 9 years
• Known pregnancy at informed consent, blood sample collection, and during study participation.

• Subjects aged 45-84 years at time of consent
• Intended to undergo a standard-of-care screening colonoscopy
• Considered by a physician or healthcare provider as being of 'average risk' for CRC
• Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
• Willing to consent to follow-up for one year as per protocol
• Able and willing to sign informed consent