Guardant Shield Colorectal Cancer Screening

NCT07436637 | Not Yet Recruiting

• 1 other identifier: 20250872
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Reminder-Only Group

EXPERIMENTAL

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

Reminder + Blood-Based Option Group

EXPERIMENTAL

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; Procedure: Blood Sample Collection

Interventions

Screening Reminder BEHAVIORAL

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.

Reminder + Blood-Based Option Group; Reminder-Only Group

Blood Sample Collection PROCEDURE

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.

Reminder + Blood-Based Option Group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Guardant Health, Inc.: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Shria Kumar, MD, MSCE

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Kattoura

CONTACT

(305) 243-6438; hkattoura@miami.edu

Shria Kumar, MD, MSCE

CONTACT

shriakumar@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Model Details: This is an interventional study that includes a 1:1 randomization into one of two communication arms: (1) a reminder for colorectal cancer screening, or (2) a reminder for screening that includes standard options and the option for a blood-based screening test, (Shield TM).

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)