Guardant Shield Colorectal Cancer Screening
Recruiting now · Not applicable
Conditions studied: Colorectal Cancer
In brief
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).
Key facts
- Study ID
- NCT07436637
- Run by
- University of Miami
- People needed
- 500
- Starts
- 2026-07-22
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 45 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Miami — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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