Guardant Shield Colorectal Cancer Screening

NCT07436637 — Not applicable, Recruiting, 500 participants, University of Miami

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07436637
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, screening
Enrollment	500 (Estimated)
Sponsor	University of Miami (Other); collaborators: Guardant Health, Inc.
Conditions	Colorectal Cancer
Interventions	Screening Reminder, Blood Sample Collection (Behavioral, procedure)
Dates	start 2026-07-22, primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-02-27, last updated 2026-10-16
Locations	1 site in United States

-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).

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Reminder-Only Group	Experimental	Behavioral: Screening Reminder	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.
Reminder + Blood-Based Option Group	Experimental	Behavioral: Screening Reminder; Procedure: Blood Sample Collection	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.

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.
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.

+Outcome measures

Primary outcomes

Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months [Up to 6 months]: Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months.

+Eligibility

Sex: All, ages: 45 Years to 85 Years, 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

+Locations (1)

Facility	City	Country	Status
University of Miami	Miami, Florida	United States	Recruiting

+Investigators

David S Goldberg, MD, Principal investigator, University of Miami