Guardant Shield Colorectal Cancer Screening
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorUniversity of Miami
About this trial
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
Qualifiers
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.
Disqualifiers
Impaired decision-making capability/unable to provide informed consent.
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
Trial design
Treatments tested in this trial
- Screening Reminder
- Blood Sample Collection
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Miami
Lead sponsor
Guardant Health, Inc.
Collaborator
Source ClinicalTrials.gov