Guardant Shield Colorectal Cancer Screening
Recruiting · NCT07436637 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Blood Sample CollectionScreening Reminder
What this trial is about
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).
Who can take part
Age range
45 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States