Guardant Shield Colorectal Cancer Screening

This study is looking for people aged 45 to 85 who are overdue for colorectal cancer screening. The goal is to see if sending a reminder, along with the option for a new blood test called Shield™ by Guardant, helps more people complete their screening within 6 months. You would either receive a standard reminder by mail/email, or receive that reminder plus the option to give a blood sample for the Shield™ test. The study aims to enroll 500 participants and is currently unclear on its recruitment status. This research helps us understand how to encourage more people to get screened for colorectal cancer.

Study design
This is an interventional study with 500 planned participants. Participants are randomly assigned (like a coin flip) to one of two groups.
What's involved
You would receive a screening reminder. If you are in the group offered the Shield™ test and consent, you would have about 40 mL of blood drawn at a UHealth facility.
Compensation
Not stated in the trial record.
Follow-up
Your colorectal cancer screening completion will be measured up to 6 months after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07436637

Guardant Shield Colorectal Cancer Screening

Recruiting
NAAges 45–85InterventionalScreening
University of Miami
~500 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Screening ReminderBlood Sample Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months
Measured over Up to 6 months
Colorectal Cancer
1 sites across 1 states
Florida1
  • Shria Kumar, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Miami

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 MonthsUp to 6 months

    Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months.