Guardant Shield Colorectal Cancer Screening

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07436637
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Helen Kattoura
[email protected]
(305) 243-6438
Shria Kumar, MD, MSCE
[email protected]
Shria Kumar, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Austin R Dosch, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Miami· Miami, FL

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