Guardant Shield Colorectal Cancer Screening

University of Miami500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

Colorectal Cancer

Interventions

Screening ReminderBEHAVIORAL

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 CollectionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months

Central Contacts

Helen Kattoura

CONTACT

(305) 243-6438 hkattoura@miami.edu

Shria Kumar, MD, MSCE

CONTACT

shriakumar@med.miami.edu

Data from ClinicalTrials.gov

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