Shield Blood Test for Colorectal Cancer
(SOLAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the Shield test's effectiveness in detecting colorectal cancer (CRC) in individuals at average risk. Participants will undergo the Shield test, and researchers will compare the results to those of a standard colonoscopy to assess the test's performance over time. Suitable candidates have no symptoms or personal/family history of CRC and plan to take the Shield test as part of their regular health care.
As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in CRC detection.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-cancer or certain immune-modifying drugs. It's best to discuss your specific medications with the trial team.
What is the safety track record for the Shield Blood Test?
Research has shown that the Shield Blood Test is safe for individuals. The FDA has approved it, confirming that it meets safety standards for colorectal cancer screening. The test has a 10% false positive rate, meaning that out of 10 people without colorectal cancer, one might still receive a positive result. While this is not harmful to health, it could lead to unnecessary additional tests.
The Shield Blood Test is easy to administer and requires no invasive procedures, as it is simply a blood test. There are no known negative effects from using the Shield Blood Test for screening. However, discussing any concerns with a healthcare provider before participating in a clinical study is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to refine and improve post-approval protocols for colorectal cancer (CRC) screening in individuals aged 45 to 81 who are at average risk. Unlike many current options, which focus on treatment after CRC diagnosis, this study emphasizes early detection and prevention, potentially leading to better outcomes. By enrolling a diverse group of subjects who meet specific criteria, this trial hopes to gather valuable data that could enhance the effectiveness and efficiency of CRC screening processes, ultimately benefiting a broader population.
What evidence suggests that the Shield Blood Test is effective for CRC?
Research has shown that the Shield Blood Test, which participants in this trial will receive, effectively detects colorectal cancer (CRC). It accurately identifies 83 out of 100 individuals with CRC and detects 13% of advanced precancerous polyps. However, the test has a 10% false positive rate, meaning some individuals without CRC might receive a positive result. The test is cost-effective, adding $25,600 to $43,700 per quality-adjusted life-year gained compared to no screening. Additionally, over 90% of individuals adhere to the testing schedule, demonstrating high compliance.14678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Testing
Participants undergo the Shield test for CRC screening
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- Shield Blood Test
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Guardant Health, Inc.
Lead Sponsor
Citations
Effectiveness and cost-effectiveness of colorectal cancer ...
Compared to no screening, blood-based screening was cost-effective with an additional cost of $25,600–43,700 per quality-adjusted life-year gained (QALYG).
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) will have a false ...
3.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2024/shield-blood-test-colorectal-cancer-screeningShield Blood Test Approved for Colorectal Cancer Screening
Overall, in addition to its 83% sensitivity for identifying colorectal cancers and 13% of advanced precancerous polyps found by colonoscopy, the ...
4.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2025/Guardant-Health-to-Share-Data-Supporting-Critical-Role-of-Blood-Based-Testing-in-Improving-Cancer-Screening-Adherence-at-ACG-2025/default.aspxPress Releases
The findings demonstrated an over 90% adherence rate for Shield, tracking well above average screening adherence for overall CRC testing which ...
State of CRC | Shield™ by Guardant Health
Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous ...
Shield™ by Guardant Health | Official Site
Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous ...
Shield™ Colorectal Cancer Screening Blood Test Fact ...
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 ...
8.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspxGuardant Health's Shield™ Blood Test Approved by FDA ...
Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance requirements for ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.