Blood Test Screening for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve colorectal cancer screening by testing a new reminder approach for patients. Participants will receive either a standard reminder to complete their screening or a reminder with the option to try a blood test called Guardant Shield. The trial seeks individuals who have not completed a colonoscopy or stool test as required at the University of Miami. Those with a history of colorectal cancer, certain bowel diseases, or specific symptoms are not suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative screening methods that could benefit future patients.
What prior data suggests that this blood test is safe for colorectal cancer screening?
Research has shown that the Shield blood test by Guardant Health received FDA approval for colorectal cancer screening, indicating it meets safety standards. This non-invasive test requires only a blood sample to detect signs of colorectal cancer. Reports of major side effects are absent, suggesting it is generally well-tolerated. However, discussing with a healthcare provider is important to determine if this test suits individual health needs.12345
Why are researchers excited about this trial?
Researchers are excited about the Guardant Shield blood test for colorectal cancer screening because it offers a non-invasive alternative to traditional methods like colonoscopies and stool tests. Unlike these standard procedures, Guardant Shield uses a blood-based approach, making it potentially more appealing for those who are hesitant about or unable to undergo colonoscopies. The ease of taking a blood test could lead to increased screening rates, enabling earlier detection and better outcomes for patients.
What evidence suggests that the Guardant Shield blood test is effective for colorectal cancer screening?
Studies have shown that the Shield blood test, available to participants in the "Reminder + Blood-Based Option Group" of this trial, has an 83-84% sensitivity, correctly identifying colorectal cancer in 83-84% of cases. It also boasts a 90% specificity, accurately identifying 90% of individuals without the disease. However, it detects only 55-65% of early-stage colorectal cancer and misses 87% of precancerous lesions. Despite these limitations, the Shield test stands out for its high adherence rate, with 95% of patients completing the screening. This suggests it could be a helpful option for those who prefer a blood test over traditional methods.13678
Who Is on the Research Team?
Shria Kumar, MD, MSCE
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive reminders for colorectal cancer screening, with some having the option for blood-based screening
Follow-up
Participants are monitored for completion of colorectal cancer screening
What Are the Treatments Tested in This Trial?
Interventions
- Guardant Shield
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Guardant Health, Inc.
Industry Sponsor
Citations
1.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2025/Guardant-Health-Announces-Clinical-Result-Update-for-Shield-Blood-Based-Colorectal-Cancer-Screening-Test/default.aspxPress Release
The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity.
summary of safety and effectiveness data (ssed)
o Shield has a false positive rate of 10%, meaning one of 10 people who do not have Advanced Neoplasia (colorectal cancer or advanced adenoma) ...
3.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2025/Shield-CRC-Blood-Test-Demonstrates-Adherence-of-95-in-New-Study-of-20000-Patients/default.aspxShield CRC Blood Test Demonstrates Adherence of 95% ...
that the Shield blood-based screening test demonstrates patient adherence of 95% in screening for colorectal cancer (CRC). Shield is the ...
Comparative Effectiveness and Cost-Effectiveness of ... - PMC
CMSmin reduced CRC incidence by 40% and CRC mortality by 52% vs no screening. These reductions were less profound than the 68%–79% and 73%–81%, respectively, ...
5.
shieldcancerscreen.com
shieldcancerscreen.com/wp-content/uploads/LBL-000351-R1-Shield-Provider-Labeling.pdfColorectal Cancer Screening Test - Shield
Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One ...
Shield™ Blood Test for Colorectal Cancer Screening
Explore our FDA-approved Shield™ blood-based screening test. Discover how our advanced technology detects cancer early, when it's most treatable.
Shield™
Shield is a screening test to detect alterations associated with colorectal cancer from whole blood samples collected from individuals at average risk for CRC.
8.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-FDA-approved-Shield-Blood-Test-Now-Commercially-Available-in-U-S--as-a-Primary-Screening-Option-for-Colorectal-Cancer/default.aspxGuardant Health's FDA-approved Shield™ Blood Test Now ...
A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for ...
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