RecruitingRecruiting
Guardant Shield Colorectal Cancer Screening
NCT07436637 · University of Miami
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population
About this study
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).
Eligibility criteria
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
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-22
Estimated completion: 2027-04-01
Last updated: 2026-07-27
Interventions
Behavioral: Screening ReminderProcedure: Blood Sample Collection
Primary outcomes
- • Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months (Up to 6 months)
Sponsor
University of Miami · other
With: Guardant Health, Inc.
Contacts & investigators
ContactHelen Kattoura · contact · hkattoura@miami.edu · (305) 243-6438
ContactShria Kumar, MD, MSCE · contact · shriakumar@med.miami.edu
InvestigatorShria Kumar, MD, MSCE · principal_investigator, University of Miami
All locations (1)
University of MiamiRecruiting
Miami, Florida, United States