Guardant Shield Colorectal Cancer Screening

Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population

The purpose of this research is to identify individuals overdue for colon cancer screening and send them a reminder to complete their screening, which includes standard of care colonoscopy or stool-based testing. The investigators are randomizing patients (like a flip of a coin) to either receive the standard reminder by mail/email or to receive the standard reminder and have the option to provide a blood sample for screening (ShieldTM by Guardant).

Inclusion Criteria:

• Adults 45 - 85 years of age at average risk and able to provide informed consent.
• Patients overdue for a screening colonoscopy or stool-based test that was ordered by their University of Miami (UM) clinician.

Exclusion Criteria:

• Impaired decision-making capability/unable to provide informed consent.

• Patients with high-risk conditions:

  • Personal history of colorectal cancer (CRC), adenomas, or other cancers
  • Those who had a positive result on another CRC screening method within the last six months, an abnormal stool test that found blood in your stool within the last 12 months, or abnormal Cologuard (FIT-DNA Test) in the last 3 years
  • Those with Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn's disease
  • Those who have a family history of colorectal cancer (in a parent, brother, sister, or child)
  • Genetic predisposition requiring more frequent screening (such as Lynch syndrome, IBD, history of colectomy, etc.)
  • Symptoms like rectal bleeding, weight loss, or other signs for which your doctor ordered a colonoscopy - not simply as a screening tool