Guardant Shield Colorectal Cancer Screening

University of Miami

Status: Begins enrollment this month

Conditions: Colorectal Cancer

Treatments: Behavioral: Screening Reminder; Procedure: Blood Sample Collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07436637

20250872

Details and patient eligibility

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Reminder-Only Group

Experimental group

Description:

Participants in this group will receive a standard screening reminder via mailed letter or, if they have an active patient portal account through the University of Miami health (UHealth) portal. Total participation duration is approximately nine (9) months.

Treatment:

Behavioral: Screening Reminder

Reminder + Blood-Based Option Group

Experimental group

Description:

Participants in this group will receive a similar reminder, but with the additional option of completing a blood-based screening test (ShieldTM). Communication will be delivered via mailed letter or the UHealth patient portal. Total participation duration is approximately nine (9) months.

Treatment:

Procedure: Blood Sample Collection

Behavioral: Screening Reminder