Guardant Shield Colorectal Cancer Screening

Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Screening Reminder; Procedure: Blood Sample Collection

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Kattoura; Phone Number: (305) 243-6438; Email: hkattoura@miami.edu
• Study Contact Backup: Name: Shria Kumar, MD, MSCE; Email: shriakumar@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Helen Kattoura; Phone Number: (305) 243-6438; Email: hkattoura@miami.edu
      • Contact: Shria Kumar, MD, MSCE; Email: shriakumar@med.miami.edu
      • Principal Investigator: Shria Kumar, MD, MSCE
      • Principal Investigator: Austin R Dosch, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reminder-Only Group; 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.	Behavioral: Screening Reminder; Participants will receive a standard screening reminder for colorectal cancer screening via mailed letter, or via University of Miami health (UHealth) portal if they have an active active account.
Experimental: Reminder + Blood-Based Option Group; 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.	Behavioral: Screening Reminder; Participants will receive a standard screening reminder for colorectal cancer screening via mailed letter, or via University of Miami health (UHealth) portal if they have an active active account.; Procedure: Blood Sample Collection; Participants who consent to the Shield TM by Guardant screening test, will undergo blood sample collection. Approximately 40 mL of blood will be drawn at a UHealth facility into a collection tube provided by Guardant Health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months	Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Guardant Health, Inc.
• Investigators: Principal Investigator: Shria Kumar, MD, MSCE, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20250872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No