Guardant Shield Colorectal Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening Reminder, Blood Sample Collection.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 45 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population
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).
Interventions
- 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.
Primary outcome measures
- Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months [Time frame: Up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT07436637 · 20250872